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

Catalog Number	23510220
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Revision surgery due to nail breakage.The recon screwdriver did not turn, and the end cap became worn.The surgeon tried to insert the screwdriver without the rod, but the tip of the screwdriver was twisted and deformed.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer h5: executive summary.The reported event could be confirmed since the device was returned for evaluation and matches with alleged event.The visual inspection of the spreading lag screwdriver has shown that the hexagon tip is strongly damaged, and the hexagonal corners are rounded off and deformed out of their original orientation.The tip is slightly twisted in counterclockwise direction.Both damages indicate that the device was exposed to excessive forces during the end cap removal attempt.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.The operative technique t2 st 20 t2 alpha tibia optech was reviewed the end cap tibia or end cap lower extremity is removed with the screwdriver bit long and quick-lock delta handle assembly.No indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation the root cause can be attributed to user-related as we can clear signs of excessive application of force from the deformation caused at the hexagonal corners of the screwdriver and based on the operative technique the end cap tibia or end cap lower extremity is removed with the screwdriver bit long and quick-lock delta handle assembly.This is a solid screwdriver with catalog 2351-0110, which can take more torque than the slotted spreading screwdriver that was used in this case.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Revision surgery due to nail breakage.The recon screwdriver did not turn, and the end cap became worn.The surgeon tried to insert the screwdriver without the rod, but the tip of the screwdriver was twisted and deformed.Additional information - the nail did not break.Proximal tibial bone around nail breaks.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19975717
• Report Number: 0009610622-2024-00788
• Device Sequence Number: 15544456
• Product Code: HXX
• UDI-Device Identifier: 07613327361742
• UDI-Public: 07613327361742
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: Lay User/Patient
• Device Catalogue Number: 23510220
• Device Lot Number: KP495516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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: Required Intervention
• Patient Sex: Prefer Not To Disclose