MAUDE Adverse Event Report: CONMED LARGO MICROLINK, ALL-SUTURE BUTTON FIXATION SYSTEM (RADIOPAQUE); WASHER, BOLT NUT

Catalog Number ASBR-K

Device Problem Material Fragmentation (1261)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Note: this report is being resubmitted following an unsuccessful submission attempt on 2021-08-13 due to a system error.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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the device, asbr-k, was being used on approximately (b)(6) 2021 during an unknown procedure and it was reported that the surgeon did not anticipate a revision.Once he was in the surgical site and recognized how loose the first metacarpal was, he tugged on the suture and it pulled out.The procedure was completed with a 15 min surgical delay to re-implant new device.There was no injury or impact to the male patient.This report is being raised on the basis of injury due to revision surgery.

Event Description

Update: the primary (b)(6) 2020 surgery was a cmc arthroplasty.The second surgery was intended to only be a small finger trigger release and hemi-trapeziodectomy.Prior to the second surgery stt arthritis was noted with a "well-placed microlink." the current status of the patient is good.The patient is 73 years old.The sales representative reported on behalf of the customer that the device, asbr-k, was being used on approximately (b)(6) 2021 during an unknown procedure and it was reported that the ¿surgeon did not anticipate a revision.Once he was in the surgical site and recognized how loose the first metacarpal was, he tugged on the suture and it pulled out.¿ the procedure was completed with a 15 min surgical delay to re-implant new device.There was no injury or impact to the male patient.This report is being raised on the basis of injury due to revision surgery.

Manufacturer Narrative

Corrected data: d4 lot # undated health effect - clinical code section h6-changed to no clinical signs or symptoms.The reported event of ¿surgeon recognized how loose; tugged and suture pulled out¿ is confirmed.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 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 the following: preoperative and operating procedures including knowledge of surgical techniques and proper selection and placement of implants are important considerations in the successful utilization of these devices.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MICROLINK, ALL-SUTURE BUTTON FIXATION SYSTEM (RADIOPAQUE)
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• MDR Report Key: 12387742
• MDR Text Key: 269277546
• Report Number: 1017294-2021-00324
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• PMA/PMN Number: K190582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2022
• Device Catalogue Number: ASBR-K
• Device Lot Number: 1122060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR