RAPIDLOC PDS PANACRYL 228312Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705010202), received between Apr 11, 2018 and Mar 7, 2019 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, 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 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 ↗
• 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 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THE SUTURE BROKE WHEN THE SURGEON IMPLANTED THE DEVICE. THE SURGEON TRIED A SECOND SUTURE, BUT THE SUTURE BROKE AGAIN. FINALLY, THE SURGEON TRIED ANOTHER ONE AND WAS ABLE TO COMPLETE THE PROCEDURE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50867.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7639131 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THE SUTURE BROKE WHEN THE SURGEON IMPLANTED THE DEVICE. THE SURGEON TRIED A SECOND SUTURE, BUT THE SUTURE BROKE AGAIN. FINALLY, THE SURGEON TRIED ANOTHER ONE AND WAS ABLE TO COMPLETE THE PROCEDURE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50869.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7639118 ↗
• MalfunctionApr 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP THAT THE SUTURE BRIDGE BROKE ON THE CUSTOMER'S RAPIDLOC 2/0 PARACRYL 27 DEGREE WHILE TIGHTENING THE SUTURE. THE CUSTOMER USED ANOTHER RAPIDLOC 2/0 PARACRYL 27 DEGREE AND THE DEVICE WOULD NOT TIGHTEN DURING A MENISCAL REPAIR. THE CASE WAS COMPLETED WITH A THIRD LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DAMAGE TO THE MENISCUS BUT A 5 MINUTE DELAY WAS REPORTED. THE DEVICES WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7423201 ↗
• MalfunctionApr 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE SUTURE BRIDGE BROKE ON THE CUSTOMER'S RAPIDLOC 2/0 PARACRYL 27 DEGREE WHILE TIGHTENING THE SUTURE. THE CUSTOMER USED ANOTHER RAPIDLOC 2/0 PARACRYL 27 DEGREE AND THE DEVICE WOULD NOT TIGHTEN DURING A MENISCAL REPAIR. THE CASE WAS COMPLETED WITH A THIRD LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DAMAGE TO THE MENISCUS BUT A 5 MINUTE DELAY WAS REPORTED. THE DEVICES WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7423138 ↗