MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER STRIKE PLATE GAMMA3 8X250MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200070
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During insertion of the locking screw of gamma 3, the torque became hard, and the locking screw was inserted using pliers on the handle part of the screwdriver.The handle of the screwdriver was damaged in the process.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During insertion of the locking screw of gamma 3, the torque became hard, and the locking screw was inserted using pliers on the handle part of the screwdriver.The handle of the screwdriver was damaged in the process.
Additional Manufacturer Narrative
The reported event could be confirmed, since a damage at the strike plate could be identified during the evaluation.The device inspection revealed the following: the inspection of the initially without allegation returned gamma3 screwdriver strike plate has shown that the holding ring is separated from the hexagon and that a piece of the ring is broken off.The fragment was not returned for evaluation.All corners on the front of the hexagon are strongly deformed over a length of approximately 1mm.This damage is a clear sign that an attempt was made to force the hexagon into the counterpart while the hexagon was offset.This inappropriate handling finally also caused the damage to the ring.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 event was caused by inappropriate handling.If more information is provided, the case will be reassessed.

• Brand Name: SCREWDRIVER STRIKE PLATE GAMMA3 8X250MM
• 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: 20757488
• Report Number: 0009610622-2024-00921
• Device Sequence Number: 9291885
• Product Code: LXH
• UDI-Device Identifier: 04546540377647
• UDI-Public: (01)04546540377647(10)K1C28D6
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 13200070
• Device Lot Number: K1C2806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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