MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER SHAFT T2 TIBIA 3,5 X 85 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0292
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2021
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: "during removal surgery, the tip of the screwdriver was broken off when removing the end cap.The tip of the screwdriver broke off just short of the surface of the end cap, so it could not be removed.Only the lateral locking screw was removed, and the nail and end cap were left in the patient body.".
Event or Problem Description
As reported: "during removal surgery, the tip of the screwdriver was broken off when removing the end cap.The tip of the screwdriver broke off just short of the surface of the end cap, so it could not be removed.Only the lateral locking screw was removed, and the nail and end cap were left in the patient body.".
Additional Manufacturer Narrative
Correction: please refer to d9/h3 - product not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available to determine the exact root cause of the event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device disposition is unknown.

• Brand Name: SCREWDRIVER SHAFT T2 TIBIA 3,5 X 85 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13003416
• Report Number: 0009610622-2021-00819
• Device Sequence Number: 4883615
• Product Code: LXH
• UDI-Device Identifier: 04546540353283
• UDI-Public: 04546540353283
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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: 1806-0292
• Device Catalogue Number: 18060292
• Device Lot Number: K752797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2002
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown