MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD SYSTEM 26 K-WIRE FOR 4.0MM SCREW DRILL TIP THREADED TIP 1.6X150MM; ORTHOPAEDIC BONE WIRE

Model Number	OS900030-S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint wire was not returned, thus visual inspection could not be undertaken.No futher clinical information or imaging was available, thus the investigation was limited to internal reviews.Review of the device history records confirmed that the product was supplied in conformance with ortho solutions specifications.A wire from the same batch was previously tested under worst-case conditions, and the device performed as intended and fulfilled the acceptance criteria with no deviations.The root cause for the complaint condition could not be ascertained following the investigation, however the manufacture of the wire was not likely to be the contributory cause for the issue.The complaint does not suggest any new or emerging risks with the device when utilised in accordance to its intended use.
Event or Problem Description
During an orif ankle procedure, where the patient required two cannulated screws bi-malleolar, it was reported that the k-wire broke upon insertion and retained in the patient.The remnant portion of the wire was discarded by the healthcare facility.The surgical procedure proceeded successfully, and no patient injury was reported.No further complications which required medical intervention were reported.

• Brand Name: SYSTEM 26 K-WIRE FOR 4.0MM SCREW DRILL TIP THREADED TIP 1.6X150MM
• 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: 11567192
• Report Number: 3008951116-2021-00002
• Device Sequence Number: 4150890
• Product Code: HTY
• UDI-Device Identifier: 05055662956030
• UDI-Public: 010505566295603017240901101A2478
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 09/01/2024
• Device Model Number: OS900030-S
• Device Catalogue Number: OS900030-S
• Device Lot Number: 1A2478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/25/2021
• 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