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

Model Number	1210-6450S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device retained by the hospital.
Event or Problem Description
The customer reported the following event under medwatch mw5104392: "during a left femoral trochanteric nailing the first guidewire used the tip of the guidewire broke in the intramedullary canal of femur.At this time it was noted that leaving the broken metal tip in the bone as suppose to attempting to remove it would be less damaging to the patient.".
Event or Problem Description
The customer reported the following event under medwatch mw5104392: "during a left femoral trochanteric nailing the first guidewire used the tip of the guidewire broke in the intramedullary canal of femur.At this time it was noted that leaving the broken metal tip in the bone as suppose to attempting to remove it would be less damaging to the patient.".
Additional Manufacturer Narrative
The reported event could be confirmed with the help of the pictures 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.The instructions for use instructs user that: ¿when inserting a k-wire, it is imperative to continuously check the position of its tip with an image intensifier.Fluoroscopy is also necessary whenever cannulated instruments are advanced over a k-wire.Ensure that bone debris does not accumulate in the cannulation of the instrument to reduce the risk of instrument binding on the k-wire.¿.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, in general, breakage of k-wire could be due to handling failure or mechanical overstressing.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: K-WIRE GAMMA Ø3,2X450 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12790813
• Report Number: 0009610622-2021-00784
• Device Sequence Number: 19831685
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 07/31/2026
• Device Model Number: 1210-6450S
• Device Catalogue Number: 12106450S
• Device Lot Number: K06B6FB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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