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); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Nail holding screw did not loosen with normal force.Eventually, the device was removed, but damage of the nail holding screw and strike plate was observed.Damaged material that could be seen in the x-ray was removed from patient body.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was received deformed and worn out, as reported.The device inspection revealed the following: the returned screwdriver strike plate shows significant signs of extensive usage as evidenced by the appearance of the deformed surface.The hexagonal tip is heavily deformed, and the ring is missing.The missing ring was returned separately, and was found deformed and broken in 2 pieces.The grooves of the device head show significant hitting marks which indicates the application of high compression force on the head.Based on the provided information and the above investigation, the root cause was attributed to a user-related issue.The hitting marks on the head of the device may indicate that the device has been impacted with high compression force which caused the hexagonal tip to deform and the ring to break.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
Nail holding screw did not loosen with normal force.Eventually, the device was removed, but damage of the nail holding screw and strike plate was observed.Damaged material that could be seen in the x-ray was removed from patient body.

• 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: 19704706
• Report Number: 0009610622-2024-00429
• Device Sequence Number: 3569167
• Product Code: LXH
• UDI-Device Identifier: 04546540377647
• UDI-Public: 04546540377647
• 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): 09/30/2024

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: 13200070
• Device Lot Number: K06A199
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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: Female