MAUDE Adverse Event Report: STRYKER GMBH EXTRACTION HOOK, SMALL IMPLANT EXTRACTION SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066160
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the tip of the extraction hook was broken off during extraction of the fractured nail and the metal piece is retained in the patient body".
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: "the tip of the extraction hook was broken off during extraction of the fractured nail and the metal piece is retained in the patient body." update- it was additionally reported that there was a 60 minute surgical delay.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned and is not broken.However, it is completely stuck into the distal side of the nail.The device was returned and the lot and catalog were confirmed.The hook is still completely stuck to the nail, which is investigated in pi (b)(4).The hook could not be taken out of the nail, but an analysis of the proximal and distal part show that no piece of the device was broken.The tip of the hook is still intact and can be seen clearly through the oblong hole of the nail.Therefore, the event cannot be confirmed.As for the fact that the hook is completely stuck to the nail, the root cause is probably due to fragments of bone stuck between the hook and the nail, or the deformation of the hook prior or during surgery.Based on investigation, the root cause was attributed to a user related issue.The event was caused by either bone fragments stuck between the hook and the nail, or a deformation of the hook prior or during surgery.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.

• Brand Name: EXTRACTION HOOK, SMALL IMPLANT EXTRACTION SET
• 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: 17884969
• Report Number: 0009610622-2023-00345
• Device Sequence Number: 7299097
• Product Code: LXH
• UDI-Device Identifier: 04546540509994
• UDI-Public: 04546540509994
• 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): 12/04/2023

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: 18066160
• Device Lot Number: K0250C0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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 Age: 70 YR
• Patient Sex: Female