MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2020
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 biceps repair procedure upon inserting the ar-1662bc swivelock biocomposite the threads were damaged.Additional information received on 8/17/2020: the bone was prepped by drilling a 6.0mm lopro.After the anchor failed, the surgeon drilled a 2.5 hole and an 8.0 lopro.The surgeon used a 90 degree straight passer and passed the suture through both holes while inserting the tendon into the 8.0mm hole and tied the suture.The implant was discarded.

• Brand Name: SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10482083
• Report Number: 1220246-2020-02108
• Device Sequence Number: 19137165
• Product Code: MAI
• UDI-Device Identifier: 00888867020566
• UDI-Public: 00888867020566
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 12/31/2023
• Device Model Number: SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
• Device Catalogue Number: AR-1662BC
• Device Lot Number: 10602544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other