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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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.
Event or Problem Description
It was reported, that the eyelet disengaged from the anchor (ar-2923ps, lot 10318889) once fully inserted.The piece broke of inside the patient, but was retrieved from the patient.There was no harm or adverse event for patient, operator or third party reported.The arthroscopic labral stabilization shoulder surgery was finished successfully with the same device anyway.The surgeon had to switch the surgical technique to a 3mm suturetak.It was not necessary to do a second surgery.

• 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: 11313972
• Report Number: 1220246-2021-02573
• Device Sequence Number: 4069223
• Product Code: MAI
• UDI-Device Identifier: 00888867028036
• UDI-Public: 00888867028036
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101679
• 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
• Report Date (Section B): 02/11/2021

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 Expiration Date: 05/31/2024
• Device Model Number: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923PS
• Device Lot Number: 10318889
• 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: 02/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other