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	01/27/2021
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 during labrum re-fix surgery the device did break off while inserting.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-2923ps pushlock assembly (no batch indicator present) was received for investigation.Visual inspection identified that the peek eyelet at the distal tip of the pushlock driver had collapsed to one side, with breakage evident.The fragment generated during this event was not returned for analysis.No damage was present to the peek anchor or the remainder of the assembly.The remainder of the peek eyelet wall was assessed where it was identified that the wall thickness present fell within tolerance.As such, the observed condition is most likely the result of improper bone preparation, off-axis insertion, and/or user applied mechanical forces during insertion.It was noted that the method of bone preparation used, as well as the bone quality encountered during the procedure, were not recorded.

• 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: 11313935
• Report Number: 1220246-2021-02572
• Device Sequence Number: 17172943
• Product Code: MAI
• UDI-Device Identifier: 00888867028036
• UDI-Public: 00888867028036
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/28/2021

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: 03/31/2025
• Device Model Number: SUTR ANCH,PEEK P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923PS
• Device Lot Number: 10785934
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other