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

Model Number	1210-6450S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2023
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: "patient taken to the or for a trochanteric nail placement.Once the nail is in place, the guide pin is inserted.Insertion proved to be a delicate operation.After several unsuccessful attempts, the surgeon realized that the guide wire had broken in the femoral head.Consequence: difficult to extract, it was necessary to remove the previously placed nail, to bring out additional material and consumables additional material, additional consumables: increase in the duration of the operation, and its the duration of the operation, and its cost.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the identification of the returned wire was confirmed based on the catalog # and the lot # marked.The instrument was broken in two parts, both were returned.The surface of the wire is heavily worn out, showing multiple scratches, most probably resulting from friction with the bone during multiple usages.The uneven surface of the breakage gives indication of a cup-cone fracture (ductile), most probably resulting from excessive torsional sheer.Dimensional and material integrity inspection showed the instrument to be within specification.Based on investigation, the root cause was attributed to an user related issue.The failure was caused by excessive tortional load applied to the already heavily worn out guide wire.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "patient taken to the operating room for a trochanteric nail placement.Once the nail is in place, the guide pin is inserted.Insertion proved to be a delicate operation.After several unsuccessful attempts, the surgeon realized that the guide wire had broken in the femoral head.Consequence: difficult to extract, it was necessary to remove the previously placed nail, to bring out additional material and consumables additional material, additional consumables: increase in the duration of the operation, and its the duration of the operation, and its cost.".

• 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: 16435294
• Report Number: 0009610622-2023-00062
• Device Sequence Number: 15345848
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: K03172B
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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