MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT T15, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705015
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A plate and a screw were completely locked and the screwdriver was broken during removal procedure.Thus, the surgeon removed the screw head using a carbide drill, and the tip of the screw was removed after the plate was removed to complete the procedure.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the screwdriver bit was returned broken, as reported.The device inspection revealed the following: the received screwdriver bit shows signs of normal wear and usage.Its tip was found to be broken, the broken part was not returned.The breakage surface shows stress marks caused by an excessive contact with the fragment after the breakage.The absence of plastic deformation and a smooth surface indicate that the breakage was brittle (instantaneous), most likely due to high torsional and bending overload.Based on the above investigation, the root cause was attributed to a user related issue.The breakage of the tip most likely happened due to a torsional and bending overload during the devices explantation.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.If more information is provided, the case will be reassessed.
Event or Problem Description
A plate and a screw were completely locked and the screwdriver was broken during removal procedure.Thus, the surgeon removed the screw head using a carbide drill, and the tip of the screw was removed after the plate was removed to complete the procedure.

• Brand Name: SCREWDRIVER BIT T15, AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19820419
• Report Number: 0008031020-2024-00277
• Device Sequence Number: 18365642
• Product Code: LXH
• UDI-Device Identifier: 07613327091649
• UDI-Public: 07613327091649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: Health Professional
• Device Catalogue Number: 705015
• Device Lot Number: K023562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2022
• 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: Other
• Patient Sex: Unknown