MAUDE Adverse Event Report: STRYKER GMBH T2 - STRIKE PLATE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060150
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during primary orif (t2) for right femoral shaft fracture.The t2 strike plate was fitted to the target device and inserted whilst striking with a hammer.As the t2 strike plate was not seated correctly when struck, the threaded connection point on the device became stripped.".
Event or Problem Description
As reported: "during primary orif (t2) for right femoral shaft fracture the t2 strike plate was fitted to the target device and inserted whilst striking with a hammer.As the t2 strike plate was not seated correctly when struck, the threaded connection point on the device became stripped.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: threads of the strike plate were found damaged and stripped.The deformation of the crest of the threads indicates that an excess force has been applied from top, most probably in form of hammering as stated in the event description.Hammering was done when the threads were not aligned properly in the mating part resulting in this kind of damage.Traces of hammering are also visible in the head of strike plate near the marking area as well.Overall, the device is in extremely used condition as indicated by the worn-out surface.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 or manufacturing related problems were found during the investigation.Based on the investigation, the root cause was attributed to be a user related issue.The event was caused by hammering the misaligned strike plate inside the mating part.If more information is provided, the case will be reassessed.

• Brand Name: T2 - STRIKE PLATE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23581812
• Report Number: 0008031020-2025-02082
• Device Sequence Number: 9532678
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: 04546540196088
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 18060150
• Device Lot Number: K076843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• 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 Age: 54 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG