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 Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/24/2020
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 that a patient underwent a right shoulder arthroscopic labral repair (bankart repair 3 to 6 o'clock) procedure during which the following arhrex devices were implanted using the inserters that come with the devices: anchor suture 1.8 knotless fibertak model ar-3638 (lot 10860295), anchor bone 2.9 peek pushlock model ar-2923ps (lot 10538126), anchor bone 2.9 peek pushlock model ar-2923ps (lot 10538124), anchor suture 1.8 knotless fibertak model ar 3638 (lot 10654070) - qty 2, anchor suture 1.8 knotless fibertak model ar-3638 (lot 10668916).The inserter part of the devices were discarded at the time of the procedure.Post-op the patient was experiencing night pain and it was discovered that a foreign body was in the patient.The same surgeon performed a second surgery (b)(6) 2020, at the same facility, to remove the foreign body.The facility is unable to determine which of the six inserter devices the foreign body may have come from as they are no longer available to examine.The facility risk manager has confirmed that the facility will not be releasing the device but has confirmed the fragment will be preserved with length of time pending recommendation for the facility's legal department.

• 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: 10431344
• Report Number: 1220246-2020-02065
• Device Sequence Number: 11624864
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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: 08/04/2020
• Initial Report FDA Received Date: 08/20/2020
• 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