MAUDE Adverse Event Report: ARTHREX, INC. SWVLK TENO BIO-COMP 8X 19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SWVLK TENO BIO-COMP 8X 19.1MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2021
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 that during a shoulder arthroscopy the peek eyelet of the device broke during implantation.The broken piece was retrieved from the patient.The tendon could no longer be buried in the bone tunnel, so the surgeon had to make a complete tunnel instead of a partial one.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-1662bc-7-1).It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection confirmed that the peek forked tip is broken.The root cause of the failure mode could not be determine, but the breakage was likely caused by excessive user applied mechanical forces during insertion.

• Brand Name: SWVLK TENO BIO-COMP 8X 19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12268692
• Report Number: 1220246-2021-03484
• Device Sequence Number: 12113359
• Product Code: MAI
• UDI-Device Identifier: 00888867283596
• UDI-Public: 00888867283596
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 05/31/2024
• Device Model Number: SWVLK TENO BIO-COMP 8X 19.1MM
• Device Catalogue Number: AR-1662BCC-8-1
• Device Lot Number: 11192402
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other