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
Event or Problem Description
As reported: "the patient was taken to surgery on (b)(6) 2021 for a left femoral trochanteric nailing with gamma nail, with nerve block and under fluoroscopy.During the passing of the first guidewire, the tip of the guidewire broke in the intramedullary canal of the femur.At this time, it was noted that leaving the broken metal tip in the bone, as opposed to removing it, would be less damaging to the patient.".
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Fragment remains implanted; disposition of remainder of device is unknown.
Event or Problem Description
As reported: "the patient was taken to surgery on (b)(6) 2021 for a left femoral trochanteric nailing with gamma nail, with nerve block and under fluoroscopy.During the passing of the first guidewire, the tip of the guidewire broke in the intramedullary canal of the femur.At this time, it was noted that leaving the broken metal tip in the bone, as opposed to removing it, would be less damaging to the patient.".
Additional Manufacturer Narrative
Please note that this event is duplicate of stryker report mfr.Report # 0009610622-2021-00784 stryker internal reference number pi (b)(4).Therefore please disregard mfr.0009610622-2021-00757.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12615346
• Report Number: 0009610622-2021-00757
• Device Sequence Number: 1335095
• 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: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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 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: 09/21/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 82 KG