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

Catalog Number	ASBR-K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the device, asbr-k, microlink, all-suture button fixation system was being used on (b)(6) 2022 during a cmc carpometacarpal arthroplasty procedure and the "drill plunged through the final cortex.Her finger was in the path.No patient injury or impact.Sterile field was maintained.10 min delay to draw labs on patient and to stop the bleeding on doctor¿s finger¿.The procedure was completed.Further assessment found that the contaminated point was removed and both pieces were discarded.The doctor had blood labs drawn and was reported as being ¿fine¿.This report is being raised on the basis of injury due to drilling through finger.
Additional Manufacturer Narrative
Reported event is inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, the reported failure 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 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 0.006.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MICROLINK, ALL-SUTURE BUTTON FIXATION SYSTEM (RADIOPAQUE)
• Common Device Name: WASHER, BOLT NUT
• 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: 14111089
• Report Number: 1017294-2022-00045
• Device Sequence Number: 13983707
• Product Code: HTN
• UDI-Device Identifier: 20845854648893
• UDI-Public: (01)20845854648893(17)261210(10)1213114
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K190582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ASBR-K
• Device Lot Number: 1213114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic