MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK P-LCK,2.9X 12.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2020
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 via fda medwatch letter (mw509611) that the following incident was reported by a facility: ¿a patient had scheduled outpatient right shoulder arthroscopy with repair in 2020.At return visit to provider an x-ray noted a foreign body in the right shoulder.Patient had a second procedure to remove the foreign body.Foreign body suspected to be broken inserter device for a knotless fibertak anchor from arthrex.Manufacturer information does indicate that the anchor insertion equipment can break during the application process.This is not part of the surgical count.So it would not have been detected during or at the conclusion of the procedure.It would have not been evident to the surgeon at the anchor placement that there was a breakage.¿ the fda medwatch letter also listed the following arthrex devices under concomitant medical products: anchor suture 1.8 knotless fibertak model ar-3638 lot 10860295 exp 3/31/2025.Anchor bone 2.9 peek pushlock model ar-2923ps lot 10538126 exp 11/30/2024.Anchor bone 2.9 peek pushlock model ar-2923ps lot 10538124 exp 11/30/2024.Anchor suture 1.8 knotless fibertak model ar-3638 lot 10654070 exp 1/31/2025 (qty 2).Anchor suture 1.8 knotless fibertak model ar-3638 lot 10668916 exp 2/28/2025.The medwatch report contained an event date of (b)(6) 2020.It is unknown at time of report if this date was the original surgery date or the second surgery date.

• Brand Name: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10537576
• Report Number: 1220246-2020-02155
• Device Sequence Number: 2676262
• Product Code: MAI
• UDI-Device Identifier: 00888867028036
• UDI-Public: 00888867028036
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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: 11/30/2024
• Device Model Number: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923PS
• Device Lot Number: 10538126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other