MAUDE Adverse Event Report: ARTHREX, INC. BUTTON, PEC REPAIR; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	BUTTON, PEC REPAIR
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	05/26/2020
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 by a patient's legal representative that on (b)(6) 2018 the patient underwent a right shoulder arthroscopic repair of their rotator cuff.During the surgery the following arthrex products were implanted; ar-2324bcc (lot: unknown) qty.1 // biocomposite swivelock suture anchor.Ar-2266 (lot: 10146727) qty.1 // pec button.The operative report indicates there were no apparent complications and that the surgery went as expected.Post-surgery, the patient was expectedly limited and restricted in most functions.By all accounts, the patient's shoulder was doing "great" up until (b)(6) 2019 - which was about 1 year and 8 months post-op.On this date, the patient reported that they were simply "toweling off'' their back after a shower and felt/heard an audible "pop" in their right shoulder accompanied by an excruciating pain.The patient also began to experience a freezing/paralyzing sensation in their shoulder.This caused the patient to return to their surgeon for evaluation/treatment.The surgeon evaluated the patient and noted the terrible pain they were experiencing.The surgeon ordered radiology of the patient's shoulder, which did not reveal any apparent fractures or tears.The surgeon then prescribed pain medication, provided a corticosteroid injection, and ordered an mri of the patient's shoulder.In a subsequent appointment, the surgeon informed the patient that the mri was inconclusive and that there was nothing definitive that could attribute to their extensive pain and shoulder "catching".The surgeon recommended the patient undergo an arthroscopic surgery of the shoulder.On (b)(6) 2020, the patient underwent another right shoulder arthroscopic surgery with the same surgeon who performed the primary.Operative notes from the revision surgery reveals that upon entering the shoulder joint, the surgeon encountered "multiple small white loose bodies that were apparently from a broken anchor".The surgeon also noted anchor pieces embedded within surrounding tissue.During the revision surgery the surgeon performed extensive debridement of scar tissue suture and removal of multiple loose bodies of broken suture anchor.The operative note also states there was debridement of the scar in the acromion around the periphery of the rotator cuff and medial up against the acromion.There was extensive probing of the rotator cuff in the subacromial space and there was no tearing present.One week post-op, the patient had an increased rom and their pain levels had improved.

• Brand Name: BUTTON, PEC REPAIR
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11339060
• Report Number: 1220246-2021-02594
• Device Sequence Number: 16364610
• Product Code: MBI
• UDI-Device Identifier: 00888867026537
• UDI-Public: 00888867026537
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BUTTON, PEC REPAIR
• Device Catalogue Number: AR-2266
• Device Lot Number: 10146727
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR