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	Defective Component (2292); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
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
As reported: "left femoral trochanteric fracture.The spring part of the screwdriver was damaged while inserting the set screw, and the screw could not be fastened.The surgery was completed with a replacement.".
Event or Problem Description
As reported: "left femoral trochanteric fracture.The spring part of the screwdriver was damaged while inserting the set screw, and the screw could not be fastened.The surgery was completed with a replacement.".
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 provided flexible set screwdriver shows several signs of usage.The flexible spiral is deformed.The outer spiral windings are partly uncoiled and broken; the inner spiral windings are slightly constricted and deformed.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.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.These damages are the result of high torsional forces during rotating in counterclockwise direction.It cannot be excluded that the screwdriver was used in an abnormal manner.If any further information is provided, the complaint report will be updated.

• 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; GM D-24232
• MDR Report Key: 11016016
• Report Number: 0009610622-2020-00991
• Device Sequence Number: 3944389
• Product Code: LXH
• UDI-Device Identifier: 04546540592545
• UDI-Public: 04546540592545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: K0F2A0B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1