MAUDE Adverse Event Report: STRYKER GMBH SPREADING RECON LAG SCREWDRIVER BIT IMN INSTRUMENTS

Catalog Number	23510220
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
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
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The received spreading lag screwdriver is having a strongly damaged and deformed hexagon tip.The corner of the hexagonal tip is almost rounded due to excess metallic contact with the mating part with strong forces involved.The tip is slightly twisted in the anticlockwise direction.Both damages indicate that the device was exposed to excessive torsional forces in counterclockwise direction during the end cap removal attempt.Furthermore, a hardness test according to (b)(4) 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.Also, as per operative technique the end cap is removed with the screwdriver bit long and quick-lock delta handle assembly.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: SPREADING RECON LAG SCREWDRIVER BIT IMN INSTRUMENTS
• 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: 21536602
• Report Number: 0008031020-2025-00380
• Device Sequence Number: 18155279
• Product Code: HXX
• UDI-Device Identifier: 07613327361742
• UDI-Public: (01)07613327361742(10)K129EBF
• 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): 06/04/2025

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: 23510220
• Device Lot Number: KP493071
• 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: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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