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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/20/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): ORTHO SOLUTIONS UK LTD; unit 5, west station business; spital road; maldon, essex CM9 6 FF; UK CM9 6FF
• Manufacturer Contact: samuel chong ; unit 5, west station business; spital road; maldon, essex CM9 6-FF ; UK CM9 6FF
• MDR Report Key: 11567192
• MDR Text Key: 257208797
• Report Number: 3008951116-2021-00002
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 05055662956030
• UDI-Public: 010505566295603017240901101A2478
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: OS900030-S
• Device Catalogue Number: OS900030-S
• Device Lot Number: 1A2478
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other