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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The conical extractor was visually inspected and the proximal tip of the extractor is partly broken off.The broken-off piece was not returned for investigation.The breakage surface shows the typical structure of breakage in a ductile manner due to bending overload.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with 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 the investigation, the root cause can be attributed to user-related as breakage happened due to the application of bending overload.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "intraoperative breakage.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "intraoperative breakage.".

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19321241
• Report Number: 0009610622-2024-00192
• Device Sequence Number: 6338439
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: KSS161511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2016
• 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: Prefer Not To Disclose