RAPIDLOC PDS PANACRYL 228310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705010189), received between Aug 22, 2018 and Aug 22, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2018Positioning Failure; Positioning Failure

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THERE WAS A DEPLOYMENT ISSUE WITH TWO OF HIS 0 DEGREE RAPIDLOC STRAIGHT NEEDLES. ACCORDING TO THE REPORT, THE SURGEON PULLED TRIGGER ON THE MENISCAL APPLIER AND THE PLASTIC BACK STOP WAS POSITIONED CORRECTLY. THE SURGEON TOOK OUT THE MENISCAL APPLIER AND WAS PUSHING DOWN THE SUTURE WITH THE PUSHER TO PUSH DOWN THE BLUE TOP HAT AND IT WOULD NOT SYNCH WITH THE PLASTIC BACK STOP. THE SURGEON CUT THE SUTURES AND LOADED ANOTHER NEEDLE TO USE IN THE MENISCAL APPLIER. HE THEN DEPLOYED THE SECOND NEEDLE, THE PLASTIC BACK STOP WAS POSITIONED CORRECTLY, AND WHEN PUSHING DOWN THE BLUE TOP HAT WITH THE PUSHER, THE KNOT TIED BEHIND THE BLUE TOP HAT CAME LOOSE CAUSING THE SURGEON TO LOOSE TENSION AND WAS UNABLE TO SYNCH THE TOP HAT TO THE PLASTIC BACK STOP. THE SURGEON REMOVED THE SUTURE AND USED A 3RD NEEDLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE NEEDLES WERE DISCARDED BY THE CUSTOMER ALREADY. NOTHING FELL OR BROKE OFF INSIDE THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806228 ↗
• MalfunctionAug 22, 2018Positioning Failure; Positioning Failure

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THERE WAS A DEPLOYMENT ISSUE WITH TWO OF HIS 0 DEGREE RAPIDLOC STRAIGHT NEEDLES. ACCORDING TO THE REPORT, THE SURGEON PULLED TRIGGER ON THE MENSICAL APPLIER AND THE PLASTIC BACK STOP WAS POSITIONED CORRECTLY. THE SURGEON TOOK OUT THE MENISCAL APPLIER AND WAS PUSHING DOWN THE SUTURE WITH THE PUSHER TO PUSH DOWN THE BLUE TOP HAT AND IT WOULD NOT SYNCH WITH THE PLASTIC BACK STOP. THE SURGEON CUT THE SUTURES AND LOADED ANOTHER NEEDLE TO USE IN THE MENISCAL APPLIER. HE THEN DEPLOYED THE SECOND NEEDLE, THE PLASTIC BACK STOP WAS POSITIONED CORRECTLY, AND WHEN PUSHING DOWN THE BLUE TOP HAT WITH THE PUSHER, THE KNOT TIED BEHIND THE BLUE TOP HAT CAME LOOSE CAUSING THE SURGEON TO LOOSE TENSION AND WAS UNABLE TO SYNCH THE TOP HAT TO THE PLASTIC BACK STOP. THE SURGEON REMOVED THE SUTURE AND USED A 3RD NEEDLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE NEEDLES WERE DISCARDED BY THE CUSTOMER ALREADY. NOTHING FELL OR BROKE OFF INSIDE THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806170 ↗