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	Unintended Radiation Exposure (4565)
Date of Event	09/28/2022
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
The customer reported that: "procedure: osteosynthesis for femoral neck fracture - placement of gamma long nail.During the operation, at the time of the aiming for the cervical screw, use of a threaded kirchner wire.Several sights are performed under x-ray control in front and in profile.During the operation, the smooth part and the threaded part broke, the distal tip was found in the nail eyelet.Consequence(s) of the adverse event : increase in the duration of the procedure.Radiation exposure ++ for the operating team and the patient.Recovery action(s) taken: recovery of the threaded tip under x-ray with a long instrument.Use of a new wire and completion of the procedure.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the identification of the device was confirmed based on the catalog # and the lot # marked.Major deformation can be observed on the k-wire, which is highly bent.The tip of the k-wire is broken off, with the fragment being returned.The surface of the breakage gives evidence of a ductile fracture, which is indicated by the major deformation of the k-wire's tip and a non-uniform fracture surface.A dimensional and a material integrity inspection show the device being in accordance with the specifications.Based on investigation, the root cause was attributed to an user related issue.The deformation and the breakage were likely caused by excessive bending and torsional load applied without the k-wire being well aligned.As a reminder, the instructions for use clearly state: " 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." 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
The customer reported that: "procedure: osteosynthesis for femoral neck fracture - placement of gamma long nail.During the operation, at the time of the aiming for the cervical screw, use of a threaded kirchner wire.Several sights are performed under x-ray control in front and in profile.During the operation, the smooth part and the threaded part broke, the distal tip was found in the nail eyelet consequence(s) of the adverse event : increase in the duration of the procedure radiation exposure ++ for the operating team and the patient recovery action(s) taken: recovery of the threaded tip under x-ray with a long instrument.Use of a new wire and completion of the procedure.".

• 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: 15672664
• Report Number: 0009610622-2022-00478
• Device Sequence Number: 6462749
• 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: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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 Model Number: 1210-6450S
• Device Catalogue Number: 12106450S
• Device Lot Number: K0EFE91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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