MAUDE Adverse Event Report: STRYKER GMBH K-WIRE GAMMA Ø3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	12106450S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2024
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: "an event take place yesterday, it was in the agreement of the consultant themselves that the situation was unavoidable and it was a clinical situation for the patient.We had a k wire break but it was due to a pathological nature within the femur bone.The person had multiple sclerotic regions of bone and these dense regions were causing deflections and it was completely unavoidable.However, there was a break of a k-wire.It was a gamma antegrade nailing with a long nail and it was the k wire itself that was broken during the insertion or in preparation for the lag screw.And the basis for it was the clinical presentation of multiple sclerotic bone which was causing deflections and challenges in getting the correct trajectory for the tip apex distance.Further details: the procedure was completed successfully through the use of further k wires.Consultant opted to leave broken fragment of k wire in situ and progressed normally.Only adverse event is a retained fragment of k wire in the neck of the femur.Tip apex distance of lag screw was acceptable given the circumstance but not ideal as per consultant feedback it was unavoidable.".
Additional Manufacturer Narrative
Please note correction to section d9/h3 the device was discarded by the customer.The reported event could be confirmed by the provided images.A device inspection was not possible since the affected device was not returned but with the image of broken k-wire we can confirm the event.Threaded portion of the k-wire is found broken with multiple turning marks all over the periphery of the k-wire.The broken part is left inside the patient and no images / radiograph are available for it.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, it was stated in the event details that the patient had multiple sclerotic regions of bone and these dense regions were causing deflections.It could not be excluded that the aforementioned fact has played a role in the breakage.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "an event take place yesterday, it was in the agreement of the consultant themselves that the situation was unavoidable and it was a clinical situation for the patient.We had a k wire break but it was due to a pathological nature within the femur bone.The person had multiple sclerotic regions of bone and these dense regions were causing deflections and it was completely unavoidable.However, there was a break of a k-wire.It was a gamma antegrade nailing with a long nail and it was the k wire itself that was broken during the insertion or in preparation for the lag screw.And the basis for it was the clinical presentation of multiple sclerotic bone which was causing deflections and challenges in getting the correct trajectory for the tip apex distance.Further details: the procedure was completed successfully through the use of further k wires.Consultant opted to leave broken fragment of k wire in situ and progressed normally.Only adverse event is a retained fragment of k wire in the neck of the femur.Tip apex distance of lag screw was acceptable given the circumstance but not ideal as per consultant feedback it was unavoidable.".

• Brand Name: K-WIRE GAMMA Ø3,2X450 MM
• 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: 18691083
• Report Number: 0009610622-2024-00065
• Device Sequence Number: 15536777
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• 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): 05/20/2024

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: 12106450S
• Device Lot Number: K187E0B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown