MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0233
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: screwdriver is strongly bent at the flexible part and single wires are broken out.
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned device matches the reported failure mode.The device inspection revealed the following: the received set screwdriver show significant traces of intense and frequent use as evident by scratches on the shaft and slightly worn out drive.The flexible spring of the set screwdrivers was significantly bent and torn from between (wires broken).This is a clear indication of a prolonged twisting and bending application of the set screwdriver, which is its intended function.However, the manner of breakage indicates towards a repetitive twisting and ultimate breakage due to repetitive cyclic stress.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.The device was manufactured in 2011 so it can be said that it performed its function in the previous surgeries as intended without any failure.Since it has been long in use thus a normal weakened structural integrity of the spiral is deemed plausible.A review of the labelling did not indicate any abnormalities.Based on the above investigation, the root cause was attributed to a user related issue.The breakage and bending of the spiral of the screwdriver was a function of repetitive bending and twisting motion, contributed by weakened structural integrity due to a long period of usage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: screwdriver is strongly bent at the flexible part and single wires are broken out.

• Brand Name: SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3 4 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10208282
• Report Number: 0009610622-2020-00305
• Device Sequence Number: 14054700
• Product Code: LXH
• UDI-Device Identifier: 04546540592545
• UDI-Public: 04546540592545
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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 Model Number: 1320-0233
• Device Catalogue Number: 13200233
• Device Lot Number: K912644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1