MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER T20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703539
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: during a removal of an axsos plate and screws, the screwdriver broke during use, based on the available information it is unknown if the device being broken resulted in debris which required invasive retrieval.There was a reported surgical delay of 2-3 hours.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to d9 - the device was not returned for evaluation.The reported event could be confirmed, since pictures of the screwdriver were provided by the reporter.The tip was broken in several pieces and detached from the screwdriver shaft.However, the provided pictures are not clear and detailed enough to identify the lot number of the device, the breakage pattern or any other relevant details that could help identify the root cause of the event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: during a removal of an axsos plate and screws, the screwdriver broke during use, based on the available information it is unknown if the device being broken resulted in debris which required invasive retrieval.There was a reported surgical delay of 2-3 hours.

• Brand Name: SCREWDRIVER T20
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19613115
• Report Number: 0008031020-2024-00252
• Device Sequence Number: 6140890
• Product Code: LXH
• UDI-Device Identifier: 04546540693778
• UDI-Public: 04546540693778
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 11/05/2024

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: 703539
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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