BIOKNOTLESS ORTHOCORD ETHIBOND 212722Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886705002085), received between Jul 13, 2018 and Jul 14, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 other recalls cover devices cleared under the same FDA submission (K040827, K070925, K150209); they may or may not involve this specific model.

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.

Recalls naming this device

1. Apr 13, 2023Class IIOpen, Classified

   IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time

   Z-1680-2023 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, A BIOKNOTLESS RAPIDE W/ORTHOCORD DEVICE WAS USED. ACCORDING TO THE REPORT, THE SURGEON DRILLED AND INSERTED THE ANCHOR AS NORMAL BUT WHEN HE PULLED THE INSERTER HANDLE OUT TO FIND THAT HALF THE ANCHOR WAS STILL ATTACHED. IT WAS REPORTED THAT THE SURGERY CONTINUED THEY DRILLED AND INSERTED ANOTHER ANCHOR. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325790 ↗
• MalfunctionMay 19, 2023Break; Break

  THE IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2023, A BIOKNOTLESS RAPIDE W/ORTHOCORD DEVICE WAS USED. ACCORDING TO THE REPORT, THE END OF THE DRIVER ENDED UP BREAKING OFF AND STAYING IN THE SCREW. IT WAS FURTHER REPORTED THAT THE ANCHOR WAS REMOVED AND REPLACED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. IT WAS REPORTED THAT THE PATIENT RECOVERED AND HAD NO NEGATIVE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16966262 ↗
• MalfunctionMar 31, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING UNKNOWN PROCEDURES ON UNKNOWN DATES, A BIOKNOTLESS RAPIDE W/ORTHOCORD DEVICE WAS USED. ACCORDING TO THE REPORT, FROM ¿TIME TO TIME¿ THE CUSTOMER EXPERIENCED INSERTER TIP BREAKAGE WHERE THERE WAS PRESSURE AND FLEX APPLIED TO THE ANCHOR INSERTER TO SEAT IT CORRECTLY BUT A SMALL AMOUNT OF THE TIP WAS MISSING WHEN REMOVED. IT WAS FURTHER REPORTED THAT THE SURGEON WAS AWARE THAT FOREIGN BODIES WERE LEFT IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16655676 ↗
• MalfunctionMar 23, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING UNKNOWN PROCEDURES ON UNKNOWN DATES, A BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE WAS USED. ACCORDING TO THE REPORT, FROM ¿TIME TO TIME¿ THE CUSTOMER EXPERIENCED INSERTER TIP BREAKAGE WHERE THERE WAS PRESSURE AND FLEX APPLIED TO THE ANCHOR INSERTER TO SEAT IT CORRECTLY BUT A SMALL AMOUNT OF THE TIP WAS MISSING WHEN REMOVED. IT WAS FURTHER REPORTED THAT THE SURGEON WAS AWARE THAT FOREIGN BODIES WERE LEFT IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16601532 ↗
• MalfunctionJan 22, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP REPORTED VIA PHONE THAT DURING A POSTERIOR LABRAL SHOULDER PROCEDURE THE DISTAL TIPS OF TWO OF THEIR BIOKNOTLESS BR ANCHORS WITH ORTHOCORD BROKE DURING INSERTION AS SOON AS THE SURGEON WENT TO TAP WITH THE MALLET. THE SALES REP STATED THAT THE SURGEON WAS OFF AXIS AND THAT THE BONE QUALITY OF THE PATIENT WAS AVERAGE TO HARD BONE. THE SALES REP CONFIRMED THAT THE BROKEN PIECES WERE REMOVED AND THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTER DELAY. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED. 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; Not Applicable

  MAUDE report 8266948 ↗
• MalfunctionJan 22, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP REPORTED VIA PHONE THAT DURING A POSTERIOR LABRAL SHOULDER PROCEDURE THE DISTAL TIPS OF TWO OF THEIR BIOKNOTLESS BR ANCHORS WITH ORTHOCORD BROKE DURING INSERTION AS SOON AS THE SURGEON WENT TO TAP WITH THE MALLET. THE SALES REP STATED THAT THE SURGEON WAS OFF AXIS AND THAT THE BONE QUALITY OF THE PATIENT WAS AVERAGE TO HARD BONE. THE SALES REP CONFIRMED THAT THE BROKEN PIECES WERE REMOVED AND THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTER DELAY. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED.. 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; Not Applicable

  MAUDE report 8266945 ↗
• MalfunctionJan 21, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER POSTERIOR BANKART REPAIR PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S BIOKNOTLESS BR ANCHOR WITH ORTHOCORD DEVICE BROKE IN HALF HORIZONTAL UPON INSERTION. THE SALES REP STATED THAT THE BROKEN PIECES WERE REMOVED AND CONFIRMED THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS HARD BONE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. 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 8264819 ↗
• MalfunctionDec 11, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LABRAL REPAIR- SHOULDER STABILISATION, THE TIP OF THEIR BIOKNOTLESS RAPIDE ANCHOR BROKE WHILE BEING IMPLANTING. SURGEON STATED THAT THE IMPLANT WAS INSERTED AT SHALLOW ANGLE AND NOT FULLY SEATED IN BONE CAUSING TIP TO BREAK ON IMPACT. JNJ REPRESENTATIVE WAS NOT PRESENT AT THIS TIME, BUT JNJ REPRESENTATIVE WAS PRESENT DURING REMOVAL OF SUTURE AND TIP. IT WAS REPORTED THAT THE WOUND SEARCHED FOR REMNANTS AND IRRIGATED. ACTION TAKEN TO MANAGE THE ISSUE DURING THE PROCEDURE: REMOVAL OF REMNANTS AND THOROUGH IRRIGATION USING SHAVER SUCTION. FOLLOWING EXPLORATION OF JOINT TO LOCATE TIP OF IMPLANT. THERE WAS A 20 MINUTE DELAY TO PROCEDURE. THE SURGEON MADE THE DECISION THAT THE ANCHOR WOULD BE REQUIRED TO COME IN FROM A SHALLOW ANGLE AND THAT IT WOULD NOT BE POSSIBLE TO IMPLANT IT INTO THE ORIGINALLY INTENDED BONE. THEREFORE THE PROCEDURE WAS COMPLETED WITHOUT ATTEMPTING ANOTHER IMPLANT AND AN ADDITIONAL BONE HOLE. IT WAS REPORTED THAT THE SURGEON LEFT THE ORIGINAL BONE HOLE, INSTEAD DECIDING THAT THE REPAIR WAS SATISFACTORY WITHOUT ANOTHER ANCHOR. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150955 ↗
• MalfunctionNov 5, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED TWO OF THE CUSTOMER'S BIOKNOTLESS RAPIDE ANCHORS BROKE DURING A SHOULDER PROCEDURE. HE STATED THE FIRST ANCHOR BROKE IN HALF UPON INSERTION. THE SURGEON TOOK OUT THE BROKEN ANCHOR AND WENT TO INSERT A SECOND ANCHOR INTO THE SAME BONE HOLE AND THE INSERTER SHAFT BENT CAUSING THE ANCHOR TO BREAK. HE REMOVED ALL BROKEN PIECES OF THE SECOND ANCHOR AS WELL AND INSERTED A THIRD ANCHOR INTO THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES. THERE WAS A TEN (10) MINUTE DELAY. ALL PIECES OF THE ANCHORS WERE DISCARDED ALREADY. THE SALES REPRESENTATIVE STATED IT WAS GOOD BONE QUALITY. HE WAS NOT PRESENT FOR THE PROCEDURE, NO FURTHER DETAILS WERE AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51788.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038349 ↗
• MalfunctionNov 5, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED TWO OF THE CUSTOMER'S BIOKNOTLESS RAPIDE ANCHORS BROKE DURING A SHOULDER PROCEDURE. HE STATED THE FIRST ANCHOR BROKE IN HALF UPON INSERTION. THE SURGEON TOOK OUT THE BROKEN ANCHOR AND WENT TO INSERT A SECOND ANCHOR INTO THE SAME BONE HOLE AND THE INSERTER SHAFT BENT CAUSING THE ANCHOR TO BREAK. HE REMOVED ALL BROKEN PIECES OF THE SECOND ANCHOR AS WELL AND INSERTED A THIRD ANCHOR INTO THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES. THERE WAS A TEN (10) MINUTE DELAY. ALL PIECES OF THE ANCHORS WERE DISCARDED ALREADY. THE SALES REPRESENTATIVE STATED IT WAS GOOD BONE QUALITY . HE WAS NOT PRESENT FOR THE PROCEDURE, NO FURTHER DETAILS WERE AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51789.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038340 ↗
• MalfunctionSep 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A LATERAL REPAIR PROCEDURE WHEN THE DOCTOR WAS DRILLING AND INSERTING THE TIP OF THE CUSTOMER'S BIO-KNOTLESS RAPIDE BR WITH ORTHOCORD, IT WAS OBSERVED THAT THE DEVICE BROKE OFF IN THE BONE HOLE. THE SALES REP STATED THAT THE DOCTOR REMOVED THE BROKEN TIP FROM THE BONE HOLE WITHOUT ANY ISSUES. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A MINUTE DELAY IN THE CASE. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS VERY HARD BONE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. 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; Not Applicable

  MAUDE report 7864254 ↗
• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT HIS BIOKNOTLESS RAPIDE ANCHOR BROKE IN HALF UPON INSERTION INTO THE BONE DURING A SHOULDER PROCEDURE. THE SURGEON REMOVED THE BROKEN ANCHOR AND ALL ITS PIECES AND INSERTED ANOTHER ANCHOR INTO THE SAME BONE HOLE WITH NO DELAYS. THE SALES REP STATED HE BELIEVES THE ANCHOR BROKE BECAUSE THE SURGEON WAS OFF AXIS WHEN INSERTING THE ANCHOR. 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 7832200 ↗
• MalfunctionAug 24, 2018Break; Break

  IT WAS REPORTED BY THE HOSPITAL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THEIR BIOKNOTLESS RAPID ANCHORS BROKE OFF THE INSERTER UPON INSERTION INTO THE BONE HOLE. THE SURGEON TOOK OUT THE ANCHOR AND USED ANOTHER ANCHOR TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THE PROCEDURE WAS DELAYED BY 15 MINUTES. 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 7812980 ↗
• MalfunctionAug 16, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING BANKART REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BIOKNOTLESS RAPIDE (BR) W/ ORTHOCORD BROKE IMMEDIATELY AFTER THE SURGEON INTRODUCED THE ANCHOR IN A CANULA AND CAUGHT THE SUTURE IN THE MOUTH OF THE ANCHOR. IT WAS REPORTED THAT THE SAME LIKE PRODUCT WAS USED TO MANAGE THE PROBLEM DURING THE PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE 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 7791857 ↗
• MalfunctionAug 16, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A SHOULDER PROCEDURE TWO OF THE CUSTOMER'S BIOKNOTLESS RAPIDE BR W/ORTHOCORD BROKE DURING INSERTION. THE SALES REP REPORTED THAT THE SURGEON DID NOT USE ANY UNUSUAL ANGLES, THAT HE DRILLED THE BONE HOLE FIRST, AND THEN USED THE HOLE FINDER NEXT. THE SURGEON THEN USED A MALLET TO INSERT THE ANCHOR 1/2 WAY INTO THE BONE HOLE THEN TAPPED THE ANCHOR IN TO FINISH INSERTING THE ANCHOR THE REST OF THE WAY IN WHEN IT BROKE INTO PIECES. THE SURGEON REPEATED THE PROCEDURE WITH ANOTHER LIKE DEVICE TO THE SAME EXACT EFFECT, BREAKING INTO PIECES ONCE HALF WAY INSERTED. BOTH ANCHORS WERE FULLY REMOVED. BOTH ANCHORS WERE OF THE SAME LOT NUMBER. THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD LIKE DEVICE BUT DIFFERENT LOT NUMBER, WITH NO PATIENT CONSEQUENCES. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. THE SALES REP STATED THAT THE SURGEON HAD USED MITEK PRODUCTS A LONG TIME. THE SALES REP REMOVED THREE REMAINING UNOPENED, UNUSED ANCHORS FROM THE CUSTOMER THAT WERE OF THE SAME LOT NUMBER AND IS RETURNING THESE FOR EVALUATION. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50970.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788352 ↗
• MalfunctionAug 16, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A SHOULDER PROCEDURE TWO OF THE CUSTOMER'S BIOKNOTLESS RAPIDE BR W/ORTHOCORD BROKE DURING INSERTION. THE SALES REP REPORTED THAT THE SURGEON DID NOT USE ANY UNUSUAL ANGLES, THAT HE DRILLED THE BONE HOLE FIRST, AND THEN USED THE HOLE FINDER NEXT. THE SURGEON THEN USED A MALLET TO INSERT THE ANCHOR 1/2 WAY INTO THE BONE HOLE THEN TAPPED THE ANCHOR IN TO FINISH INSERTING THE ANCHOR THE REST OF THE WAY IN WHEN IT BROKE INTO PIECES. THE SURGEON REPEATED THE PROCEDURE WITH ANOTHER LIKE DEVICE TO THE SAME EXACT EFFECT, BREAKING INTO PIECES ONCE HALF WAY INSERTED. BOTH ANCHORS WERE FULLY REMOVED. BOTH ANCHORS WERE OF THE SAME LOT NUMBER. THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD LIKE DEVICE BUT DIFFERENT LOT NUMBER, WITH NO PATIENT CONSEQUENCES. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. THE SALES REP STATED THAT THE SURGEON HAD USED MITEK PRODUCTS A LONG TIME. THE SALES REP REMOVED THREE REMAINING UNOPENED, UNUSED ANCHORS FROM THE CUSTOMER THAT WERE OF THE SAME LOT NUMBER AND IS RETURNING THESE FOR EVALUATION. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50971.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788340 ↗
• MalfunctionAug 7, 2018Break; Break

  DURING SHOULDER REPAIR SURGERY, THE IMPLANT BROKE OFF INSERTION SHAFT WHEN SURGEON WAS PASSING THE TIP THROUGH ORTHOCORD LOOP, AS PER SURGICAL TECHNIQUE. THE BROKEN PIECE WAS RETRIEVED. ANOTHER IMPLANT WAS OPENED, AND THE SURGERY WAS COMPLETED UNEVENTFULLY. DELAY WAS 5-10 MINUTES. NO ADVERSE EVENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7757514 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED BY THE PURCHASING AGENT FROM THE FACILITY THAT ONE OF THEIR BIOKNOTLESS RAPID ANCHOR BROKE DURING AN UNKNOWN PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7703941 ↗
• MalfunctionJul 17, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR THAT THE TIPS ON THREE OF THE CUSTOMER'S BIOKNOTLESS RAPIDE (BR) ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SALES REP STATED THE ANCHORS WERE STILL ON THE INSERTER AT THE TIME AND THE SURGEON USED TOO MUCH TENSION. THE SALES REP STATED THE SURGEON COMPLETELY REMOVED EACH BROKEN ANCHOR, PREPPED THE BONEHOLE AGAIN AND INSERTED ANOTHER LIKE ANCHOR IN THE SAME BONEHOLE WITH NO PATIENT CONSEQUENCES BUT A 10 MINUTE DELAY. THE SALES REP STATED THE SURGEON WAS OFF-AXIS AND USED TOO MUCH TENSION. THE SALES REP SAID THE BONE QUALITY WAS HARD AND THE PATIENT WAS YOUNG BUT HE HAD NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697285 ↗
• MalfunctionJul 17, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR THAT THE TIPS ON THREE OF THE CUSTOMER'S BIOKNOTLESS RAPIDE (BR) ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SALES REP STATED THE ANCHORS WERE STILL ON THE INSERTER AT THE TIME AND THE SURGEON USED TOO MUCH TENSION. THE SALES REP STATED THE SURGEON COMPLETELY REMOVED EACH BROKEN ANCHOR, PREPPED THE BONE HOLE AGAIN AND INSERTED ANOTHER LIKE ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT A 10 MINUTE DELAY. THE SALES REP STATED THE SURGEON WAS OFF-AXIS AND USED TOO MUCH TENSION. THE SALES REP SAID THE BONE QUALITY WAS HARD AND THE PATIENT WAS YOUNG BUT HE HAD NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697283 ↗
• MalfunctionJul 17, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR THAT THE TIPS ON THREE OF THE CUSTOMER'S BIOKNOTLESS RAPIDE (BR) ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SALES REP STATED THE ANCHORS WERE STILL ON THE INSERTER AT THE TIME AND THE SURGEON USED TOO MUCH TENSION. THE SALES REP STATED THE SURGEON COMPLETELY REMOVED EACH BROKEN ANCHOR, PREPPED THE BONEHOLE AGAIN AND INSERTED ANOTHER LIKE ANCHOR IN THE SAME BONEHOLE WITH NO PATIENT CONSEQUENCES BUT A 10 MINUTE DELAY. THE SALES REP STATED THE SURGEON WAS OFF-AXIS AND USED TOO MUCH TENSION. THE SALES REP SAID THE BONE QUALITY WAS HARD AND THE PATIENT WAS YOUNG BUT HE HAD NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697281 ↗
• MalfunctionJul 13, 2018Break; Break

  THE SALES REP REPORTED THAT DURING A SHOULDER REPAIR THAT HIS BIOKNOTLESS RAPIDE (BR) ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SALES REP STATED THE SURGEON WAS OFF-AXIS. THE ANCHOR WAS STILL ON THE INSERTER AND BROKE IN THE MIDDLE. THE SURGEON COMPLETELY REMOVED THE BROKEN ANCHOR AND INSERTED ANOTHER LIKE ANCHOR IN THE SAME BONE HOLE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP STATED THE MALE PATIENT HAD GOOD BONE QUALITY. THE SALES REP DID NOT KNOW OF ANY PREEXISTING MEDICAL CONDITIONS OR MEDIATION THE PATIENT WAS TAKEN NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7687599 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040827, K070925, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1168-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1164-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1165-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1171-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1163-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1167-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1169-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1162-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1166-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1170-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-0316-2012 · Oct 31, 2011 · Terminated
  DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate pos

…and 5 more.