MAUDE Adverse Event Report: STRYKER GMBH EXTRACTION ROD, CONICAL T2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060353
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
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: "extraction rod is broken off at the front".
Additional Manufacturer Narrative
Please note the correction to d4 lot#.The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned extraction rod could be confirmed based on the catalog # and the lot # marked.The tip of the instrument is broken, as reported.The detached fragment was not returned.The surface of the breakage gives indication of a ductile fracture, resulting most probably from continuous torsion overload applied.Material integrity inspection confirmed that the device was manufactured according to the material specification.Based on investigation, the root cause was attributed to an user related issue.The breakage was most probably caused by constant overload being applied.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
As reported: "extraction rod is broken off at the front".

• Brand Name: EXTRACTION ROD, CONICAL T2
• 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: 21306908
• Report Number: 0008031020-2025-00243
• Device Sequence Number: 15656638
• Product Code: LXH
• UDI-Device Identifier: 04546540196446
• UDI-Public: 04546540196446
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/29/2025

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: 18060353
• Device Lot Number: KSS2243AV
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• 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