MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, BICEPS TENODESIS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPLANT SYSTEM, BICEPS TENODESIS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported during a subpec biceps tenodesis procedure the surgeon was using the ar-1662s-1 biceps tenodesis implant system.Upon inserting the swivelock, the swivelock broke in half.The rep reported the surgeon removed the broken portion of the implant, and tugged on the suture to test fixation of the remaining swivelock that was remained in the tunnel.The remaining portion of the swivelock proved to be secure and was holding the tendon in the drill hole.The surgeon was content with the outcome of the repair and the case was completed.The retrieved broken portion of the swivelock was discarded.

• Brand Name: IMPLANT SYSTEM, BICEPS TENODESIS
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9693142
• Report Number: 1220246-2020-01648
• Device Sequence Number: 11368200
• Product Code: MAI
• UDI-Device Identifier: 00888867096028
• UDI-Public: 00888867096028
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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 Expiration Date: 08/31/2024
• Device Model Number: IMPLANT SYSTEM, BICEPS TENODESIS
• Device Catalogue Number: AR-1662S-1
• Device Lot Number: 10387102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other