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

Catalog Number 00505004200

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  malfunction  

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

The distributor reported on behalf of their customer that the 00505004200, c-wire pak double ended orthopaedic wire, was being used during mallet finger fixation procedure, on (b)(6) 2021.When it was reported, ¿it was reported that c-wire was broken at the dip part when it was inserted from the distal phalanx of the ring finger to be used for mallet finger fixation.The broken c-wire was removed by incising the dip.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Upon further assessment it was found that a fragment had fallen into the patient and was retrieved.The procedure was completed with an unknown device and there was no report of delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.The manufacturing documents from the device history record have not been reviewed because the lot number is not known.The lot history was not conducted because the lot number is not known.A two-year review of complaint history revealed there has been a total of two complaints, regarding two 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).Per the instructions for use, the user is advised the following: that c-wires are to be inserted into the tissue using a compatible wire driver and manipulated as necessary according to the surgical needs.The user is also advised that the c-wires should only be used with wire drivers that are designed to drive wires having longitudinal flats.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the 00505004200, c-wire pak double ended orthopaedic wire, was being used during mallet finger fixation procedure on (b)(6) 2021 when it was reported, ¿it was reported that c-wire was broken at the dip part when it was inserted from the distal phalanx of the ring finger to be used for mallet finger fixation.The broken c-wire was removed by incising the dip.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Upon further assessment it was found that a fragment had fallen into the patient and was retrieved.The procedure was completed with an unknown device and there was no report of delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16511639
• MDR Text Key: 310955859
• Report Number: 1017294-2023-00017
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00505004200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Ethnicity: Non Hispanic