MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C, 5.5X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	PEEK SWIVELOCK C, 5.5X19.1MM
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/19/2021
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 after an initial surgery the anchor became loose and migrated out.A revision surgery was performed on (b)(6) 2021.During the revision surgery the tendon was fixated with a new corkscrew anchor.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-2323pslc peek screw (no batch indicator provided) was received for investigation.Visual inspection identified remnants of tissue within the threads of the peek screw.No major thread damage was noted to the screw, and no major breakage was noted.As the suture construct was not returned along with the screw, it is unknown if suture breakage contributed to the reported fixation issue.The root cause of the reported event remains undetermined without the return of the suture construct.It was also identified that the method of bone preparation used in the procedure, as well as the bone quality encountered, were not provided.

• Brand Name: PEEK SWIVELOCK C, 5.5X19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11259287
• Report Number: 1220246-2021-02533
• Device Sequence Number: 17190590
• Product Code: MAI
• UDI-Device Identifier: 00888867026797
• UDI-Public: 00888867026797
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191226
• 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): 06/04/2021

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: PEEK SWIVELOCK C, 5.5X19.1MM
• Device Catalogue Number: AR-2323PSLC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 06/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other