MAUDE Adverse Event Report: STRYKER GMBH IMPLANT EXTRACTION SET - CONICAL EXTRACTOR, MALE, LEFT HAND SMALL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066169
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The conical extractor is broken at the tip.The fragment was not returned.The fracture surface appears relatively rough, smooth and without plastic deformation, which suggests a brittle fracture.The fracture was most likely induced by the user applying excessive force or torque while trying to extract the screw.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 the investigation, the root cause can be attributed to user-related related as the breakage happened in a brittle manner caused by the application of excessive force during explantation.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the tip of the conical extractor was damaged during screw removal.".

• Brand Name: IMPLANT EXTRACTION SET - CONICAL EXTRACTOR, MALE, LEFT HAND SMALL
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23359100
• Report Number: 0008031020-2025-01988
• Device Sequence Number: 8964535
• Product Code: LXH
• UDI-Device Identifier: 04546540510051
• UDI-Public: (01)04546540510051(11)171115(10)K0A1326
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 18066169
• Device Lot Number: KSS179528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 78 KG