MAUDE Adverse Event Report: STRYKER GMBH IMPLANT EXTRACTION SET - CONICAL EXTRACTOR, MALE, LEFT HAND 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066172
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
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: "'description according to the operating room: intraoperatively, the thread of insert 1806-6172 broke.The insert became stuck in the thread and could no longer be disconnected.'' update september 22, 2025.How was the event resolved? other surgical trays and instruments were opened.Was the explanted implant a stryker/wright medical or from competition? the product was one from the competition.If stryker/wright medical, why did the surgeon decide to explant the device? patient request.If the device was broken or damaged: was there hard/dense bone? it was hard dense bone.Was there any debris reported? were they all removed from the surgical field/patient? all debris could be removed.
Event or Problem Description
As reported: "'description according to the operating room: intraoperatively, the thread of insert 1806-6172 broke.The insert became stuck in the thread and could no longer be disconnected.'' update september 22, 2025 ¿ how was the event resolved? other surgical trays and instruments were opened.¿ was the explanted implant a stryker/wright medical or from competition? the product was one from the competition.- if stryker/wright medical, why did the surgeon decide to explant the device? patient request ¿ if the device was broken or damaged: - was there hard/dense bone? it was hard dense bone - was there any debris reported? were they all removed from the surgical field/patient? all debris could be removed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned broken and jammed with the t-handle.The device inspection revealed the following: as a received condition, the conical extractor and the t-handle were found assembled and could not be separated using normal force.These components are not intended to be assembled together, as they belong to different product systems.According to their respective operative techniques, the conical extractor should be paired with a teardrop handle from its own system, while the elastosil t-handle is designed for use with compatible instruments featuring an ao fitting.Therefore, the inability to disassemble the components resulted from off-label use by the user.The extractor is fractured at its tip.The fracture surface appears smooth and relatively flat, with no visible signs of plastic deformation.This is characteristic of a brittle fracture, which most likely resulted from torsional overload and excessive force applied during use.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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 breakage was caused by the use of torsional overload and excessive force applied during use, and the disassembling impaired was caused by off-label use of the devices, as they should not be assembled together.If more information is provided, the case will be reassessed.

• Brand Name: IMPLANT EXTRACTION SET - CONICAL EXTRACTOR, MALE, LEFT HAND 4 MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23316684
• Report Number: 0008031020-2025-01933
• Device Sequence Number: 4838483
• Product Code: LXH
• UDI-Device Identifier: 04546540510082
• UDI-Public: 04546540510082
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/29/2025

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: 18066172
• Device Lot Number: KSS242060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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