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

Model Number	1210-6450S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2020
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 is not available; hospital retained.
Event or Problem Description
It was reported that during a right hip revision, the tips of 2 k-wires broke off in the patient's bone.The tips were retrieved out of the patient.Surgery was completed successfully with no surgical delay.
Additional Manufacturer Narrative
The reported event could not be confirmed.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 states: ¿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.
Event or Problem Description
It was reported that during a right hip revision, the tips of 2 k-wires broke off in the patient's bone.The tips were retrieved out of the patient.Surgery was completed successfully with no surgical delay.Additional information: "they used the k-wire to ream over with a grey revision end mill.The tip of both guide wires broke.The broken tips were retrieved without incident.".

• 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: 10347527
• Report Number: 0009610622-2020-00413
• Device Sequence Number: 10963549
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 11/30/2024
• Device Model Number: 1210-6450S
• Device Catalogue Number: 12106450S
• Device Lot Number: K08157D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 49