MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT, LONG IMN INSTRUMENTS 3.5MM

Catalog Number	23510110
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "during the t2 alpha tibia removal surgery, the end cap could not be removed, and the surgery was finished with the t2 nail remaining to the patient.Also two screwdriver tips were damaged by the torque.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The screwdriver bit was received with a broken tip and the broken tip was not returned.The broken surface of the screwdriver bit shows signs of ductile fracture due to torsional overload.The breakage surface shows a little cup type formation and the edges of the hexagonal tip also showing deformation in anticlockwise direction due to excess torsional force.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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.Based on the investigation, the root cause was attributed to be user related.The event was caused due to application of excess torsional forces while removing the end cap.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during the t2 alpha tibia removal surgery, the end cap could not be removed, and the surgery was finished with the t2 nail remaining to the patient.Also two screwdriver tips were damaged by the torque.".

• Brand Name: SCREWDRIVER BIT, LONG IMN INSTRUMENTS 3.5MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21536711
• Report Number: 0008031020-2025-00381
• Device Sequence Number: 7000186
• Product Code: HXX
• UDI-Device Identifier: 07613327376463
• UDI-Public: 07613327376463
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23510110
• Device Lot Number: KP491457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Male