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	09/19/2024
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
Customer report through sales rep that device has snapped during procedure.
Event or Problem Description
Customer report through sales rep that device has snapped during procedure.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned broken as reported.The device inspection revealed the following: visual inspection the clamping lever on the shaft of the self-holding screwdriver, extra short 3.5 mm was completely broken off in brittle manner.No evidence of excessive handling was found.The clamping sleeve with torque limiter appeared to be undamaged.Functional inspection due to breakage no function was given.Dimensional inspection dimensional inspection revealed no deficiency.Diameter and hardness were in accordance with specs.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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.The instructions for use also state that: avoid excessive workloads or wedging or twisting the instruments during the operation.In extreme cases this can lead to fracture of the instrument.Failure to observe this procedure can lead to fracture of the instrument and represents a high risk for the patient and the surgeon.In the course of the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure.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.With available information the root cause was breakage due to overload which was regarded being user related.With available information a deficiency of the device was not determined.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20457736
• Report Number: 0009610622-2024-00866
• Device Sequence Number: 7765343
• Product Code: LXH
• UDI-Device Identifier: 04546540520418
• UDI-Public: 04546540520418
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: KMW351802
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2019
• 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