MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD K-WIRE TROCAR TIP 2.0MM X 150MM; ORTHOPAEDIC BONE WIRE

Model Number	OS292200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the wire fracture was unable to be ascertained.Review of the device history records for the batch revealed that the devices were supplied in conformance with pre-determined specifications.No anomalies or deviations were noted in the manufacture of this batch of k-wire which may have contributed to the failure of the k-wire during operation.Thus, the manufacture of the batch is therefore not likely to have been a cause for the k-wire fracture reported.The investigation was limited as there was a lack of clinical information, and the complaint device was discarded, thus not allowing for visual inspection or testing for material anomalies and insight into the mode of fracture.The trend analysis shows that this is the first complaint for the wire, and the failure rate is deemed very low at 0.0009%.There were no new or emerging risks identified as a result of this complaint.
Event or Problem Description
During an orif procedure for a left proximal humerus fracture, as the surgeon was using a k-wire to stabilise the fracture, part of the wire broke, leaving a portion of it inside of the patient's bone.The surgical procedure was successful, and no injury or complication for the patient was reported.No additional clinical information was provided, and the device was discarded.The k-wire is manufactured from implant-grade 316lvm stainless steel.

• Brand Name: K-WIRE TROCAR TIP 2.0MM X 150MM
• Common Device Name: ORTHOPAEDIC BONE WIRE
• Manufacturer (Section D): ORTHO SOLUTIONS UK LTD; unit 5, west station business; spital road; maldon, essex CM9 6 FF; UK CM9 6FF
• MDR Report Key: 10611728
• Report Number: 3008951116-2020-00008
• Device Sequence Number: 14204151
• Product Code: HTY
• UDI-Device Identifier: 05055662923124
• UDI-Public: 010505566292312417250701101118894
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: 07/01/2025
• Device Model Number: OS292200
• Device Lot Number: 1118894
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other