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

Model Number	1806-6178
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
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: "difficulty extracting an implant whilst using a stryker extraction set.Patient had a femoral fracture.".
Event or Problem Description
As reported: "difficulty extracting an implant whilst using a stryker extraction set.Patient had a femoral fracture.".
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the outer surface of the received device shows signs of frequent usage.Overall no damage or deformation was observed on the device.A pre-surgical function test was performed on the returned device and was found to be fully functional.Hence the alleged issue could be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation and information provided the exact root cause could not be established.However, most likely the failure seems to be a user-related issue.If any further information is provided, the complaint report will be updated.

• Brand Name: FORCEPS, 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: 15624696
• Report Number: 0009610622-2022-00467
• Device Sequence Number: 15049266
• Product Code: LXH
• UDI-Device Identifier: 04546540510136
• UDI-Public: 04546540510136
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1806-6178
• Device Catalogue Number: 18066178
• Device Lot Number: KP470697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown