RAPIDLOC PDS PANACRYL 228311Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705010196), received between Mar 14, 2018 and Jan 29, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2019Melted; Melted

  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 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284667 ↗
• MalfunctionJan 25, 2019Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A KNEE REPAIR THAT THE CUSTOMER'S RAPIDLOC 12 NEEDLE AND THEIR RAPIDLOC 27 DEGREE NEEDLE DOUBLE DEPLOYED ALL AT ONCE. THE PROCEDURE WITH ANOTHER LIKE DEVICE IN THE SAME BONE TUNNEL WITH NO PATIENT CONSEQUENCES. THERE WAS A 5 MINUTE DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8277729 ↗
• MalfunctionAug 17, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING MENISCAL REPAIR, IT WAS OBSERVED THAT AFTER IMPLANT OF RAPIDLOC 12 DEGREE NEEDLE, W/ #2/0 PANACRYL (PLA/PDS) DEVICE, THE KNOT DID NOT WORK/ HELD IN PLACE AS A KNOT. IT WAS REPORTED THAT THE IMPLANT WAS REMOVED. IT WAS REPORTED THAT THE PROCEDURE WAS ENDED WITH SAME LIKE PRODUCT. IT WAS REPORTED THAT THE PROCEDURE WAS EXTENDED FIVE MINUTES DUE TO THE EVENT. IT WAS REPORTED THAT THE IMPLANT WAS DISCARDED AND WILL NOT BE SENT IN. 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 7793473 ↗
• MalfunctionAug 16, 2018Device-Device Incompatibility; Device-Device Incompatibility

  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)(6) FEMALE WITH PREEXISTING MEDICAL CONDITIONS. NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790329 ↗
• MalfunctionAug 16, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 3 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 7788610 ↗
• MalfunctionAug 16, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 2 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 7788609 ↗
• MalfunctionMar 14, 2018Break; Break

  PHYSICIAN REPORTED THAT DURING SURGERY PROCEDURE SUTURE HAS BEEN BROKEN. TO PROCEDURE COMPLETED PHYSICIAN USED ANOTHER ONE PRODUCT THE SAME TYPE. NO CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7338385 ↗