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

Catalog Number	18066169
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2025
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: "the extraction of 4.0ccs was difficult, the screw head was removed and a conical extractor small was used, but the tip broke off and remained in the screw.The inside of the crown drill was clogged.Finally, all extraction was completed".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned broken as reported.The device inspection revealed the following: 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.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.Based on investigation, the root cause was attributed to a user related issue.The event was caused by excessive force applied to the instrument when trying to extract the screw.As a reminder, the instructions for use state the following: « always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.Avoid excessive workloads or wedging or twisting the instruments during the operation.In extreme cases this can lead to fracture of the instrument.» 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: "the extraction of 4.0ccs was difficult, the screw head was removed and a conical extractor small was used, but the tip broke off and remained in the screw.The inside of the crown drill was clogged.Finally, all extraction was completed".

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21368802
• Report Number: 0008031020-2025-00277
• Device Sequence Number: 8437684
• Product Code: LXH
• UDI-Device Identifier: 04546540510051
• UDI-Public: 04546540510051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 18066169
• Device Lot Number: KSS179528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/21/2025
• 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: 18 YR
• Patient Sex: Male