MAUDE Adverse Event Report: CONMED LARGO C-WIRE PAK DOUBLE ENDED ORTHOPAEDIC WIRE; PIN, FIXATION, SMOOTH

Model Number 00505004400

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report (mw5110511) on 5july22.The current complaint database has been researched for this event and there were no findings.The report was found to be written against the 00505004400, c-wire pak double ended orthopaedic wire, stating that it was being used during a podiatry surgery on (b)(6) 2022 when it was reported that the ¿patient was undergoing podiatry surgery and c-wire.062 spade (1.57mm) fractured and retained piece of 1.3cm remained in the medial cuneiform.¿ further assessment found the procedure was completed with no delay to the surgery.The device was on the sterile field and was then utilized in surgery under sterile conditions.The device broke during surgery and did fragment.The medical decision made by the surgeon was to leave the fragment within the bone.It was reported the patient was not injured, no medical/surgical intervention or extended hospitalization was required for the patient.The patient is said to be on the "usual post-operative course." this report is being raised on the basis of injury due to a report of the medical decision made by the surgeon to leave the fragment within the bone.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence was provided therefore the reported event could not be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only event for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised that c-wires are to be inserted into tissue using a compatible wire driver and manipulated as necessary according to surgical needs.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created due to the receipt of a medwatch report (mw5110511) on 5july22.The current complaint database has been researched for this event and there were no findings.The report was found to be written against the 00505004400, c-wire pak double ended orthopaedic wire, stating that it was being used during a podiatry surgery on (b)(6) 2022 when it was reported that the ¿patient was undergoing podiatry surgery and c-wire.062 spade (1.57mm) fractured and retained piece of 1.3cm remained in the medial cuneiform.¿ further assessment found the procedure was completed with no delay to the surgery.The device was on the sterile field and was then utilized in surgery under sterile conditions.The device broke during surgery and did fragment.The medical decision made by the surgeon was to leave the fragment within the bone.It was reported the patient was not injured, no medical/surgical intervention or extended hospitalization was required for the patient.The patient is said to be on the "usual post-operative course." this report is being raised on the basis of injury due to a report of the medical decision made by the surgeon to leave the fragment within the bone.

• Brand Name: C-WIRE PAK DOUBLE ENDED ORTHOPAEDIC WIRE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 15030853
• MDR Text Key: 296042106
• Report Number: 1017294-2022-00080
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10845854029107
• UDI-Public: (01)10845854029107(17)260713(30)1(10)1117841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00505004400
• Device Catalogue Number: 00505004400
• Device Lot Number: 1177841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 156 KG
• Patient Ethnicity: Non Hispanic