MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER SHAFT, COMPRESSION T2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060263
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: driver broken while performing compression with compression screwdriver.A second screwdriver was used and procedure was completed successfully".
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: in the received screwdriver, the shaft of the screwdriver found broken from its proximal end inside the hollow head of the screwdriver where it was fixed.The proximal end of the shaft is having deformation near the breakage area which points towards a ductile failure.The microscopic view of the broken surface also shows characteristics of ductile overload failure where the applied force causes first a permanent distortion of the material with subsequent fracture.Further the device looks very old and intensively used as indicated by discoloration and wear marks on the device.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 investigation, the root cause was attributed to a user related issue.The failure was caused by applying too much force onto the screwdriver during the described turning of the compression screw.In this relation following statement of the t2 humeral nailing system operative technique can be pointed out: ¿the short tissue protection sleeve is removed and the compression screw is gently tightened utilizing the two-finger technique." if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: driver broken while performing compression with compression screwdriver.A second screwdriver was used and procedure was completed successfully".

• Brand Name: SCREWDRIVER SHAFT, COMPRESSION T2
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21339904
• Report Number: 0008031020-2025-00251
• Device Sequence Number: 3759134
• Product Code: LXH
• UDI-Device Identifier: 04546540196330
• UDI-Public: 04546540196330
• 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): 05/02/2025

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: 18060263
• Device Lot Number: K547164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2007
• 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