RAPIDLOC PDS PANACRYLRecalls & reported problems across all models

We found 3 models of RAPIDLOC PDS PANACRYL by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2018 and Mar 7, 2019 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RAPIDLOC PDS PANACRYL problems

RAPIDLOC PDS PANACRYL models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RAPIDLOC PDS PANACRYL 228312

  STAPLE, FIXATION, BONE
  11 reports
• RAPIDLOC PDS PANACRYL 228311

  STAPLE, FIXATION, BONE
  7 reports
• RAPIDLOC PDS PANACRYL 228310

  STAPLE, FIXATION, BONE
  2 reports

Recent RAPIDLOC PDS PANACRYL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2019Disconnection; Disconnection

  IT WAS REPORTED BY THE AFFILIATE THAT THE SUTURE WAS DETACHED FROM MAIN PART SPONTANEOUSLY. THE PROCEDURE WAS DELAYED ABOUT 15 MINUTES. THE AFFILIATE REPORTED NO CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTS THAT AN ALTERNATIVE DEVICE WAS ABLE TO BE USED AND SURGERY WAS COMPLETED. THE DEBRIS WAS REMOVED AND THERE ARE NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: Not Applicable

  MAUDE report 8401582 ↗
• 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 8277735 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionAug 6, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE KNOT, WHICH WAS USED TO TIGHTEN THE SUTURE, ON THE RAPIDLOC 27 DEGREE NEEDLE PULLED RIGHT THROUGH. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITH NO DELAY. 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 7754015 ↗
• MalfunctionJul 14, 2018Break; Break

  IT WAS REPORTED WHEN THE SURGEON RELEASED THE SYSTEM, THE FIXATION WENT THROUGH THE MENISCUS AND THE SUTURE RUPTURED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A SAME LIKE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7688490 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT THE KNOT WAS ALREADY BROKEN BEFORE THE SURGEON TRIED TO PUSH IT. CHANGED ANOTHER ONE TO COMPLETE. NO ADVERSE EVENT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678289 ↗
• MalfunctionJul 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE SUTURES ON TWO OF THE CUSTOMER'S RAPIDLOC 27 DEGREE NEEDLE WITH PANACRYL BROKE WHILE THE SURGEON WAS PULLING TENSION TO PUSH THE KNOTS DOWN DURING A MENISCAL PROCEDURE. THIS HAPPENED ONE AFTER THE OTHER AND THE SURGEON REMOVED BOTH ANCHORS AFTER THE SUTURES BROKE AND REPLACED THEM WITH 12 DEGREE NEEDLE ANCHORS. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS A TEN MINUTE DELAY. BOTH DEVICES WERE DISCARDED BY THE CUSTOMER ALREADY. THE SALES REP WAS NOT PRESENT, NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667126 ↗
• MalfunctionJul 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE SUTURES ON TWO OF THE CUSTOMER'S RAPIDLOC 27 DEGREE NEEDLE WITH PANACRYL BROKE WHILE THE SURGEON WAS PULLING TENSION TO PUSH THE KNOTS DOWN DURING A MENISCAL PROCEDURE. THIS HAPPENED ONE AFTER THE OTHER AND THE SURGEON REMOVED BOTH ANCHORS AFTER THE SUTURES BROKE AND REPLACED THEM WITH 12 DEGREE NEEDLE ANCHORS. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS A TEN MINUTE DELAY. BOTH DEVICES WERE DISCARDED BY THE CUSTOMER ALREADY. THE SALES REP WAS NOT PRESENT, NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667113 ↗

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