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 Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/15/2020
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.Tip remains in patient; remainder of device unknown.
Event or Problem Description
As reported: gamma 3.2mm x 450 k-wire, threaded tip of wire separated from rest of wire on insertion into great trochanter.Surgeon was using k-wire through the cannulated awl, tip broke on 3rd pass through the awl.Patient with metastatic legions in gt, surgeon reported that ¿it didn¿t feel as though the wire was going through any particularly dense bone during the 3 passes.Broken threaded tip of k-wire left in-situ, procedure continued without any impact.Additionally reported: approximate 2-3 minute delay to procedure.
Event or Problem Description
As reported: gamma 3.2mm x 450 k-wire, threaded tip of wire separated from rest of wire on insertion into great trochanter.Surgeon was using k-wire through the cannulated awl, tip broke on 3rd pass through the awl.Patient with metastatic legions in gt, surgeon reported that ¿it didn¿t feel as though the wire was going through any particularly dense bone during the 3 passes.Broken threaded tip of k-wire left in-situ, procedure continued without any impact.Additionally reported: approximate 2-3 minute delay to procedure.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned for evaluation, but an x-ray was provided which confirms the alleged failure.A device inspection was not possible since the affected device was not returned but an x-ray was provided which confirms that the k-wire, indeed, broke around the tip, from the region where threads start.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.An x-ray was shared through which the failure was confirmed.The same x-ray was presented to our medical expert to obtain his opinion about the tip of the k-wire staying inside the patient, given the fact that patient had metastatic lesions in the greater trochanter.He stated the following: the threat/harm to the patient is more then limited.This happens from time to time.There is a potential conflict if an endoprothesis will be implanted at a later stage, but there should be no risk resulting from this metal piece.Neither mechanically nor biocompatibility wise.More information, as well as the affected device must be available in order to determine the exact root cause of the failure.However, based on the event itself, it can be said that multiple insertion of the same k-wire under pressure could have led to slight twisting and bending to an extent of diminishing of its structural integrity, leading to breakage.If the device is returned or any additional information is provided, the investigation will be reassessed.

• 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; DE D-24232
• MDR Report Key: 10140827
• Report Number: 0009610622-2020-00287
• Device Sequence Number: 16984525
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 01/31/2025
• Device Model Number: 1210-6450S
• Device Catalogue Number: 12106450S
• Device Lot Number: K0DE0B4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 70