MAUDE Adverse Event Report: ARTHREX, INC. SWVLK TENO BIO-COMP 7X 19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SWVLK TENO BIO-COMP 7X 19.1MM
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032)
Date of Event	02/07/2019
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 an initial labral and slap repair procedure, the following arthrex parts were implanted on (b)(6) 2017: ar-1662bcc-7 // lot: 10153102.Ar-2324bcc-2 // lot: 10140067.Ar-2923bc // lot: 10140969.Approximately a year after the initial procedure, the patient started experiencing severe pain and limited range of motion in their left shoulder.The surgeon performed a revision left shoulder scope, lysis of adhesions and removal of loose body procedure on (b)(6) 2019.The loosened bicep anchor (ar-1662bcc-7 / lot: 10153102) was retrieved shattered in multiple small pieces, which had debrided adhesion's onto the patient's rotator cuff.The primary and revision procedure were performed at the same facility by the same surgeon.No additional arthrex parts were implanted during the revision procedure.The following arthrex parts were explanted during the revision procedure: ar-1662bcc-7 // lot: 10153102.Additional information provided via medical records on may 6, 2019: according to the medical records provided the patient had continued pain from (b)(6) 2017 through (b)(6) 2018.The physical therapy records dated (b)(6) 2017 stated "shoulder is a little sore on arrival today - thinks he rolled onto it when sleeping".The patient continued to consistently note shoulder pain and the records report difficulty with overhead lifting from the end of (b)(6) 2017 to (b)(6) 2018, when the pt was terminated early.The patient was later seen (b)(6) 2019 and reported left shoulder pain.The operative noted dated (b)(6) 2019 noted "diagnostic arthroscopy revealed adhesions in the rotator cuff interval and a loosened biceps tenodesis anchor.This was then retrieved in multiple small pieces using a grasper and shaver.Debrided adhesions rotator cuff interval.Subscapularis supraspinatus grossly intact.Bursal side supraspinatus grossly intact.

• Brand Name: SWVLK TENO BIO-COMP 7X 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: 8627538
• Report Number: 1220246-2019-01101
• Device Sequence Number: 11320754
• Product Code: MAI
• UDI-Device Identifier: 00888867020603
• UDI-Public: 00888867020603
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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: 07/31/2019
• Device Model Number: SWVLK TENO BIO-COMP 7X 19.1MM
• Device Catalogue Number: AR-1662BCC-7
• Device Lot Number: 10153102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-2923BC (LOT 10140969), AR-2324BCC-2 (LOT 10140067)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR