NA 228000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705009930), received between Aug 16, 2018 and Feb 19, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2019Positioning Failure; Positioning Failure

  THE SALES REP REPORTED THE CUSTOMER'S MENISCAL APPLIER WOULD NOT DEPLOY THEIR RAPIDLOC 12 DEGREE NEEDLE FAR ENOUGH INTO THE MENISCUS DURING A MENISCAL REPAIR. THIS CAUSED THE ANCHOR TO JAM IN THE DEVICE AND NOT DEPLOY CORRECTLY. THE SURGEON COULD NO LONGER PULL THE TRIGGER FOR THE APPLIER ONCE THIS HAPPENED. HE USED A DIFFERENT METHOD TO COMPLETE THE PROCEDURE AND THERE WAS A 10 MINUTE DELAY. THE COMPLAINT DEVICES WERE ALREADY DISCARDED BY THE CUSTOMER. THE SALES REP STATED IT WAS A (B)(4) YEAR OLD FEMALE WITH PREEXISTING MEDICAL CONDITIONS. NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351029 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT THE MENISCAL APPLIER WITH THE RAPIDLOC 2/0 PARACRYL 27 DEGREE NEEDLE HANDLE BROKE DURING A KNEE SCOPE PROCEDURE. THERE WAS NO DEBRIS LEFT IN THE PATIENT AND WHERE THE DEVICE BROKE STAYS OUTSIDE THE PATIENT. THE CASE WAS COMPLETED WITH A BACK UP DEVICE AND ANOTHER NEEDLE USING THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A MINUTE DELAY IN THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290558 ↗
• MalfunctionJan 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR THE CUSTOMERS MENISCAL APPLIER KEPT JAMMING. THE DEPLOYMENT SPRING KEPT STICKING WHEN THE TRIGGER WAS PULLED. TO COMPLETE THE CASE THE SURGEON OPENED A NEW MENISCAL APPLIER AND A NEW NEEDLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THIS IS REPORT 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284669 ↗
• MalfunctionAug 27, 2018Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR, THE LID OF THE CUSTOMER'S MENISCAL APPLIER FOR RAPIDLOC WHEN OPENED WOULD NOT ALLOW THE IMPLANT TO BE LOADED INTO THE GUN. THE SALES REP REPORTED THAT THE HINGE ON THE DOOR APPEARS TO BE BROKEN AND WHEN THE DEVICE IS SHAKEN YOU CAN HEAR LOOSE PARTS INSIDE THE GUN. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE DEVICE IS BEING RETURNED FOR EVALUATION. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER. THE SALES REP WAS NOT PRESENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819983 ↗
• MalfunctionAug 16, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE REPAIR, IT WAS OBSERVED THAT THE CUSTOMER'S MENISCAL APPLIER DEVICE JAMMED THE RAPIDLOC 12 DEGREE NEEDLE, W/ #2/0 PANACRYL (PLA/PDS) DEVICE TWO TIMES WHEN FIRED. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE AND IMPLANT WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT AND HAD NO FURTHER DETAILS. THE CUSTOMER ALREADY DISCARDED THE DEVICES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788613 ↗
• MalfunctionAug 16, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A MENISCAL REPAIR, IT WAS OBSERVED THAT THE APPLICATOR ON THE MENISCAL APPLIER EA DEVICE BROKE AT THE SECOND SEAM AND COULD NO LONGER BE TRIGGERED. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788115 ↗