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

Catalog Number ASBNR-K

Device Problem Material Fragmentation (1261)

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

Event Date 01/14/2021

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 customer reported that the device, asbnr-k, was being used on (b)(6) 2021 during a rhizarthrose procedure when "the wire broke during drilling through the drill guide." assessment information was requested three times and no response has been received.The microling was used as an alternate device.There was a 10 minute delay.There was no report of injury, medical intervention or hospitalization for the (b)(6) patient due to this event.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported event of "the wire broke during drilling" is not confirmed.The device will not be returned for evaluation; however, a photograph was provided.Review of the photograph shows the wire appears to be intact however the loop section of the device is detached.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 9 complaints, regarding 9 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised the following: inspect prior to use to ensure device is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on devices, to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect devices after use to ensure they have not been damaged.Devices are designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper techniques for use.Proper placement of all-suture button and backstop 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 (RADIOLUCENT)
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11306541
• MDR Text Key: 231719565
• Report Number: 1017294-2021-00066
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 20845854901295
• UDI-Public: (01)20845854901295(17)211012(10)1093663
• Combination Product (y/n): N
• PMA/PMN Number: K190516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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 Expiration Date: 10/12/2021
• Device Catalogue Number: ASBNR-K
• Device Lot Number: 1093663
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/30/2021
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 75