MAUDE Adverse Event Report: STRYKER GMBH CONICAL EXTRACTOR, FEMALE, LEFT HAND IMPLANT EXTRACTION SET Ø5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066185
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During revision surgery, screwdriver tip broken off while extracting an competitor screw from the patient body due to pediatric growth.Screw fracture and all debris were removed from patient body.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned with a stuck screw as reported.The device inspection revealed the following: visual inspection of the device indicates that a significant number of white/grey debris is present within the cannulation of the extractor, which appears to be bone fragments from the procedure.As a consequence of this material accumulation within the cannulation, the extracted screw could not be removed using normal force.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 event was caused by the user not ensuring cleanliness of the cannulation during the procedure, therefore inducing debris clogging.As a reminder, the instructions for use state the following: « users have to ensure the cleanliness of the cannulation of the instrument pre-, inter- and post operatively to make sure that bone debris does not accumulate ».If more information is provided, the case will be reassessed.
Event or Problem Description
During revision surgery, screwdriver tip broken off while extracting an competitor screw from the patient body due to pediatric growth.Screw fracture and all debris were removed from patient body.

• Brand Name: CONICAL EXTRACTOR, FEMALE, LEFT HAND IMPLANT EXTRACTION SET Ø5 MM
• 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: 21534867
• Report Number: 0008031020-2025-00377
• Device Sequence Number: 15466351
• Product Code: LXH
• UDI-Device Identifier: 04546540510204
• UDI-Public: 04546540510204
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 18066185
• Device Lot Number: K274053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2011
• 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: Male