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

Model Number	5.5MM PEEK KNOTLESS SWIVELOCK
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/24/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
Surgeon was performing a double row rotator cuff repair using ar-1927psf-475 medially and ar2323kpslc laterally.He has recently been trialing the ar-2323kpslc (knotless swivelock).After completing the majority of his double row repair, he tensioned his suture tapes that had been dunked in the swivelocks eyelet into the punched lateral hole.Two of his suture tapes snapped right at the eyelet (in the bottom of the punched swivelock hole) and came loose.This completely de threaded his double row repair with the surgery almost complete.The anchors remained in situ and he completed the rotator cuff repair with an open approach.After the case we inspected the eyelet of the knotless swivelock in a sterile packet and compared it the regular swivelock eyelet.We noticed there is a break in the rounded plastic eyelet to allow for the knotless mechanism.This break also exposes the metal inserter.We believe that this small gap made the eye lit much sharper than the regular version causing the suture tapes to snap.In the next case he did his regular double row rotator cuff repair with a regular swivelock and there was no issue, thus ruling out a technique issue.He has done hundreds of this procedure and has never had this issue with the normal swivelock.The arthrex product manager tested the same construct in the office and managed to recreate the problem.

• Brand Name: 5.5MM PEEK KNOTLESS SWIVELOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14192977
• Report Number: 1220246-2022-04783
• Device Sequence Number: 4459301
• Product Code: MAI
• UDI-Device Identifier: 10888867351346
• UDI-Public: 10888867351346
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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 Model Number: 5.5MM PEEK KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2323KPSLC
• Device Lot Number: 13335335
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown