MAUDE Adverse Event Report: CONMED LARGO C-WIRE; PIN, FIXATION, SMOOTH

Catalog Number	00505004200
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of the customer that the device, 00505004200, c-wire pak double ended orthopaedic wire, was being used on (b)(6) 2024 during a fracture of the distal phalanx of the middle finger and the ¿c-wire broke during insertion.¿.Per further assessment it was found that the fragments did fall into the surgical and were retrieved.The procedure was completed with the use of an alternate backup device.There was no impact or injury for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Additional Manufacturer Narrative
The reported event of the c-wire breaking during insertion was confirmed.Visual examination of returned used product item 00505004200, found c-wire bent and broken off at the shaft.The broken piece is approximately 1.325 of the inches.Examination was performed per 00505004200 found no issues with print critical dimensions.Root cause cannot be determined; however, based upon evaluation of the device; a possible cause of this event could be excessive force.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 complaint 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 (b)(4) reports, regarding (b)(4) devices, 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).We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the device, 00505004200, c-wire pak double ended orthopaedic wire, was being used on (b)(6) 2024 during a fracture of the distal phalanx of the middle finger and the ¿c-wire broke during insertion.¿.Per further assessment it was found that the fragments did fall into the surgical site and were retrieved.The procedure was completed with the use of an alternate backup device.There was no impact or injury for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: C-WIRE
• Common Device Name: 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20047546
• Report Number: 1017294-2024-00097
• Device Sequence Number: 15464734
• Product Code: HTY
• UDI-Device Identifier: 10845854029091
• UDI-Public: (01)10845854029091(17)280718(10)1328251
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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 Catalogue Number: 00505004200
• Device Lot Number: 1328251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic