MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS, BC; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS, BC
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported during a distal biceps repair, while attempting to insert the button, the tip of the inserter broke off from the kit ar-2260bc.All broken pieces were retrieved from the patient.No extra incisions were made.The surgeon was able to complete the procedure as planned by opening a new kit and using a new inserter.The broken device is not available for return and no pictures were taken.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11761645
• Report Number: 1220246-2021-03009
• Device Sequence Number: 14456871
• Product Code: MAI
• UDI-Device Identifier: 00888867204645
• UDI-Public: 00888867204645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Device Catalogue Number: AR-2260BC
• Device Lot Number: 12438087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1