BIOKNOTLESS ORTHOCORD ETHIBONDRecalls & reported problems across all models

We found 2 models of BIOKNOTLESS ORTHOCORD ETHIBOND by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Jul 14, 2023 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Break” (32 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

BIOKNOTLESS ORTHOCORD ETHIBOND recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 ↗

2. 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-1679-2023 · Root cause: Use error · Recall details · FDA record ↗

Most reported BIOKNOTLESS ORTHOCORD ETHIBOND problems

BIOKNOTLESS ORTHOCORD ETHIBOND models

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

• BIOKNOTLESS ORTHOCORD ETHIBOND 212722

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 recall22 reports
• BIOKNOTLESS ORTHOCORD ETHIBOND 212726

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  1 recall14 reports

Recent BIOKNOTLESS ORTHOCORD ETHIBOND adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 8, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A BANKART REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR TIP ON THE BIOKNOTLESS PLUS W/ORTHOCORD DEVICE BROKE THAT REMAINED INSIDE THE PATIENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15942351 ↗
• MalfunctionNov 23, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A BANKART REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR TIP ON THE BIOKNOTLESS PLUS W/ORTHOCORD DEVICE BROKE THAT REMAINED INSIDE THE PATIENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15857475 ↗
• InjuryFeb 7, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THAT THE THREADED PORTION OF THE INSERTED REMAINED IN THE BIOKNOTLESS PLUS W/ ORTHOCORD AFTER INSERTION. THERE'S NO ADDITIONAL INFORMATION AT THE TIME OF THE CALL. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EVENT OCCURRED DURING A SHOULDER ARTHROSCOPY AND THE CASE WAS COMPLETED DECIDING THE KEEP THE ANCHOR IN THE GLENOID OF THE PATIENT WITH THE TIP OF THE INSERTED STILL INSIDE. IT WAS REPORTED THE SURGEON DID NOT ATTEMPT TO REMOVE THE INSERTER FROM THE PATIENT AND THERE ARE NO KNOWN ADVERSE EFFECTS TO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9683924 ↗
• MalfunctionJan 23, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S BIOKNOTTLESS ANCHOR WITH ORTHOCORD WITH A QUANTITY OF TWO FAILED DURING A LABRUM REPAIR SURGICAL PROCEDURE. THE SHAFT BENT WHEN PUSHING THE ANCHOR INTO THE BONE WITH HAND, NO TAP ON BOTH DEVICES. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE FROM A DIFFERENT LOT. THERE WAS NO NEW BONE HOLE NEEDED AND BONE QUALITY WAS HARD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME 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 8270869 ↗
• MalfunctionJan 23, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S BIOKNOTTLESS ANCHOR WITH ORTHOCORD WITH A QUANTITY OF TWO FAILED DURING A LABRUM REPAIR SURGICAL PROCEDURE. THE SHAFT BENT WHEN PUSHING THE ANCHOR INTO THE BONE WITH HAND, NO TAP ON BOTH DEVICES. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE FROM A DIFFERENT LOT. THERE WAS NO NEW BONE HOLE NEEDED AND BONE QUALITY WAS HARD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME 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 8270650 ↗
• 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 ↗

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