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

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2021

Event Type  malfunction  

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 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.

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
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11259287
• MDR Text Key: 230696749
• Report Number: 1220246-2021-02533
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026797
• UDI-Public: 00888867026797
• Combination Product (y/n): N
• PMA/PMN Number: K191226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PEEK SWIVELOCK C, 5.5X19.1MM
• Device Catalogue Number: AR-2323PSLC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other