MAUDE Adverse Event Report: STRYKER GMBH 2.0MM ASNIS MICRO, SOLID SCREWDRIVER, 2.0MM, AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	45-20004
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The nurse stated that during the operation the screw driver was working initially, then it stopped working and the screw driver was failing to capture the screw.The nurse stated it was then noticed by the scrub nurse that the screw driver head felt 'sharp', and the tip of it appeared to be broken off.The nurse stated the operating staff became concerned that the tip of the screw driver may have been broken off inside the patient.Suction was applied to the area, and then the tip of the screw driver that broke off was successfully retrieved from the suction device.The nurse stated that an x-ray was then performed of the area, and the surgeon was confident there were no foreign objects inside the patient.An alternate screw driver was used successfully.The broken screw driver with the broken piece off the end was put aside.No adverse consequences were reported and the procedure was otherwise completed successfully.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on the investigation, the root cause was determined to be other related factors.The failure was caused by normal wear and tear over the years.The device inspection revealed the following: the tip of the returned asnis micro screwdriver was observed completely broken off.Upon further inspection of the fractured surface; the broken tip revealed further cracks as well as rust.The condition of the device indicates that the tip must have been previously damaged / cracked.The deformation of the front part of the device indicates that high mechanical force was applied; which led to a strain hardening / embrittlement of the material which resulted in the breakage.The root cause of the failure was repeated powerful dynamically overload during use over time.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The nurse stated that during the operation the screw driver was working initially, then it stopped working and the screw driver was failing to capture the screw.The nurse stated it was then noticed by the scrub nurse that the screw driver head felt 'sharp', and the tip of it appeared to be broken off.The nurse stated the operating staff became concerned that the tip of the screw driver may have been broken off inside the patient.Suction was applied to the area, and then the tip of the screw driver that broke off was successfully retrieved from the suction device.The nurse stated that an x-ray was then performed of the area, and the surgeon was confident there were no foreign objects inside the patient.An alternate screw driver was used successfully.The broken screw driver with the broken piece off the end was put aside.No adverse consequences were reported and the procedure was otherwise completed successfully.

• Brand Name: 2.0MM ASNIS MICRO, SOLID SCREWDRIVER, 2.0MM, AO COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8913068
• Report Number: 0008031020-2019-01082
• Device Sequence Number: 19384851
• Product Code: LXH
• UDI-Device Identifier: 04546540534392
• UDI-Public: 04546540534392
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 45-20004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1