MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE, STERILE T2 FEMUR 3X285 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0050S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
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 disposition is unknown.
Event or Problem Description
The customer reported that as he was using a k-wire during the case, he noticed shards of metal - 'swarf' on the drapes.No metal was seen in the patient.The routine post op x-ray showed no evidence of shards in the patient.It happened during entry point of a tibial nail.Was a supra-patella approach to the nail.The procedure was completed using the same wire.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were 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.A review of the labeling did not indicate any abnormalities.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, the probable root cause would be but not limited to; patient factor (e.G., rigid dense bone quality), or user related (e.G., instrument was weakened / damaged while insertion, incorrect positioning or miss-drilling) etc.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The customer reported that as he was using a k-wire during the case, he noticed shards of metal - 'swarf' on the drapes.No metal was seen in the patient.The routine post op x-ray showed no evidence of shards in the patient.It happened during entry point of a tibial nail.Was a supra-patella approach to the nail.The procedure was completed using the same wire.

• Brand Name: K-WIRE, STERILE T2 FEMUR 3X285 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: 10805388
• Report Number: 0009610622-2020-00703
• Device Sequence Number: 3931837
• Product Code: LXH
• UDI-Device Identifier: 04546540195852
• UDI-Public: 04546540195852
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/04/2021

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 Expiration Date: 03/31/2025
• Device Model Number: 1806-0050S
• Device Catalogue Number: 18060050S
• Device Lot Number: K055075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1