MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LIMITED 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	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records confirmed that the product was supplied in conformance with ortho solutions specifications.The complaint wire was not returned, thus visual inspection could not be undertaken.A wire from the same batch was tested under worst-case conditions based on the clinical information, 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.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 a midfoot fusion procedure, it was reported that after inserting the 4mm headless screw under power and percutaneously over the k-wire, it was found that the k-wire tip had broken in the screw and therefore retained in the patient.The fractured k-wire tip was confirmed to have broken off via x-ray.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 LIMITED; west station business park; spital road; maldon, essex, CM9 6 FF; UK CM9 6FF
• MDR Report Key: 9812646
• Report Number: 3008951116-2020-00003
• Device Sequence Number: 1299892
• Product Code: HTY
• UDI-Device Identifier: 05055662956030
• UDI-Public: (01)05055662956030(17)240901(10)1A2478
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/10/2020
• Initial Report FDA Received Date: 03/10/2020
• 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