Other Medical Devices

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

Device outer packaging was incorrectly labeled.

Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds timeframe of each other: - The SRM module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the SRM module buffer - There is divert gate malfunction and a narrow timing window Only in this specific scenario, Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without a unique error message being generated. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the pending test orders (not yet performed) on Tube B.

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.