MAUDE Adverse Event Report: STRYKER GMBH EXTRACTION HOOK, SMALL IMPLANT EXTRACTION SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066160
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
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
As reported: "the threads on the connection between the universal rod and the extraction hook have become deformed.
Event or Problem Description
As reported: "the threads on the connection between the universal rod and the extraction hook have become deformed.
Additional Manufacturer Narrative
Correction - please refer to d4 lot number.The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned part was confirmed based on the catalog # and the lot # marked.The visual inspection revealed that the thread is severely damaged at half of its total length and the thread flanks are no longer present.A high force must have acted on them.The whole instrument surface has multiple scratches.The upper end of the instrument shows signs of impact, possibly caused by hammering.Based on investigation, the root cause was attributed to a user related issue.The incident was most probably caused by careless handling of the instrument.In the case of manufacturing-related deviations, these would have been noticed at the beginning.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.

• Brand Name: EXTRACTION HOOK, SMALL IMPLANT EXTRACTION SET
• 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: 21520624
• Report Number: 0008031020-2025-00373
• Device Sequence Number: 8378550
• Product Code: LXH
• UDI-Device Identifier: 04546540509994
• UDI-Public: 04546540509994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 18066160
• Device Lot Number: K1D9F3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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