MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE GAMMA 3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1210-6450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that during a gamma nail procedure, a k-wire broke of in the patient while performing femoral fixation.Surgeon decided to leave the broken portion in the patient.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.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.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that during a gamma nail procedure, a k-wire broke of in the patient while performing femoral fixation.Surgeon decided to leave the broken portion in the patient.

• Brand Name: K-WIRE GAMMA 3,2X450 MM
• 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
• MDR Report Key: 12206878
• Report Number: 0009610622-2021-00616
• Device Sequence Number: 4318102
• Product Code: LXH
• UDI-Device Identifier: 04546540175359
• UDI-Public: 04546540175359
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/21/2021

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 Expiration Date: 03/31/2026
• Device Model Number: 1210-6450
• Device Catalogue Number: 12106450
• Device Lot Number: K0ABDF8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1