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

Model Number	1806-6160
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
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: "during an extraction of a t2a-gt nail, the hook part broke during the process and was retained in the body of patient.".
Event or Problem Description
As reported: "during an extraction of a t2a-gt nail, the hook part broke during the process and was retained in the body of patient.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the hook of the device is not present anymore.The device inspection revealed the following: the visual inspection has shown that the received extraction hook is in a very used condition, there are many deformations all over the shaft visible, there are strong stress marks at the shaft and impact marks on top of the device.The hook is not present anymore, the smooth surface indicates that the tip of the hook was sheared off during the extraction.There are other damages visible next to the sheared off surface, these damaged indicates that there were several nail removal attempts made after the tip was not present anymore.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to 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 investigation, the root cause was attributed to a use related issue.Based on the deformed appearance on the shaft it is likely that the hook was not in full contact with the nail, this and the applied high forces did lead to the shearing off of the hook.A sharp edge at the nail, e.G at the fracture face, may also have played a certain role.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 TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 16743072
• Report Number: 0009610622-2023-00120
• Device Sequence Number: 17737128
• 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): 06/05/2023

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 Model Number: 1806-6160
• Device Catalogue Number: 18066160
• Device Lot Number: K042797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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: 48 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian