SUTURING SET, PROTECTOR MENISCUS

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 01-JUL-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT THE SURGEON WAS UNABLE TO REPAIR THE MENISCUS USING AN AR-4060S PROTECTOR MENISCUS SUTURING SET NOR WITH AN AR-4580 AND AR-4580-24 FIBERSTITCH, DUE TO THE CHRONIC NATURE OF THE LESION. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE WITH SCREW/SCREW FIXATION AND LAL AND ATTEMPTED MENISCAL REPAIR WITH NO PATIENT HARM. THE CASE WAS COMPLETED A MENISCECTOMY. THERE WAS NO DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED AND THE PATIENT'S BONE QUALITY WAS REPORTED AS GOOD. ADDITIONAL INFORMATION PROVIDED 15-JUL-2026: IT WAS FURTHER REPORTED THAT THE STATEMENT THAT THE MENISCAL LESION WAS CHRONIC AND, FOR THAT REASON, COULD NOT BE REPAIRED WAS PROVIDED BY THE SURGEON; HOWEVER, IT WAS BELIEVED THAT THE ISSUE WAS RELATED TO THE SURGICAL TECHNIQUE. THE FIRST SUTURE USING THE FIBERSTITCH IN THE POSTERIOR HORN OF THE MEDIAL MENISCUS WAS PERFORMED SUCCESSFULLY. THE SURGEON THEN PROCEEDED WITH A SECOND SUTURE USING ANOTHER FIBERSTITCH NEAR THE MENISCAL ROOT; HOWEVER, IT APPEARED THAT THE DEVICE DID NOT PENETRATE DEEPLY ENOUGH TO REACH THE POSTERIOR CAPSULE. WHEN TENSION WAS APPLIED AND THE STITCH WAS TIGHTENED, THE MENISCUS TORE, COMPROMISING THE FIRST REPAIR. THE SURGEON THEN ATTEMPTED TO PLACE ADDITIONAL SUTURES USING THE PROTECTOR DEVICE, BUT WHEN THE KNOTS WERE TIED, THE MENISCUS TORE AGAIN. AS A RESULT, THE PROCEDURE WAS CONVERTED TO A MENISCECTOMY.