MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER, SELF-HOLDING, EXTRA SHORT 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060203
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
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
Customer reported a broken device.
Event or Problem Description
Customer reported a broken device.
Additional Manufacturer Narrative
Corrected field: lot no.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received screwdriver shows signs of repetitive usage as evidenced by worn out and discolored surface.The tip of the movable blade of the screwdriver is broken and was not returned.The breakage surface shows the typical structure of a brittle fracture (smooth surface, no plastic deformation), most probably due to a bending or torsional overload applied during use.To prevent the bending, the device is laser-marked with the printing do not lever on the screwdriver sleeve.Furthermore, a hardness test according to (b)(4) on the returned item indicates the material being in accordance to 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 a user-related issue.The breakage shows signs of torsional or bending overload applied on the screwdriver during use.It can be added that since the device was manufactured approximately 12 years ago, normal wear and tear may also have contributed to the event.If more information is provided, the case will be reassessed.
Additional Manufacturer Narrative
Corrections: please refer to section h6 (results and conclusion codes).
Event or Problem Description
Customer reported a broken device.

• Brand Name: SCREWDRIVER, SELF-HOLDING, EXTRA SHORT 3.5 MM
• 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: 21164496
• Report Number: 0008031020-2025-00110
• Device Sequence Number: 18494884
• Product Code: LXH
• UDI-Device Identifier: 04546540520418
• UDI-Public: 04546540520418
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

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: 18060203
• Device Lot Number: KMW351101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 07/01/2025; 08/14/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 07/25/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2012
• 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