BIOKNOTLESS ETHIBONDRecalls & reported problems across all models

We found 2 models of BIOKNOTLESS ETHIBOND by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2018 and Aug 16, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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 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, 2023Open, 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-1677-2023 · Root cause: Use error · Recall details · FDA record ↗

Most reported BIOKNOTLESS ETHIBOND problems

BIOKNOTLESS ETHIBOND models

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

• BIOKNOTLESS ETHIBOND 212724

  Screw, fixation, bone
  1 recall4 reports
• BIOKNOTLESS ETHIBOND 212738

  STAPLE, FIXATION, BONE
  1 report

Recent BIOKNOTLESS ETHIBOND adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2022Migration; Migration

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF BIOKNOTLESS PLUS W/ETHIBOND DEVICE. IT WAS REPORTED THAT POSTOPERATIVELY TO A CAPSULO-LABRAL PROCEDURE OF THE RIGHT SHOULDER INITIALLY PERFORMED ON (B)(6) 2014 THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2015 DUE TO FAILED/LOOSE BIOKNOTLESS PLUS W/ETHIBOND DEVICE. ACCORDING TO THE REPORT, THE PATIENT HAD POSTOPERATIVE ABNORMAL OR PROLONGED PAIN, POSTOPERATIVE JOINT STIFFNESS AND POSTOPERATIVE ARTHROFIBROSIS, GIRD AND FAILED ANCHOR FIXATION ON (B)(6) 2015 . IT WAS FURTHER REPORTED THAT THE PATIENT HAD POSTOPERATIVE ANCHOR LOOSENING ON (B)(6) 2015 . THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15233857 ↗
• MalfunctionApr 23, 2019Migration; Migration

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN ARCR SURGERY THE BIOKNOTLESS ETHIBOND ANCHOR CAME OFF FROM THE BONE HOLE WHEN THE SURGEON IMPLANTED INTO THE PATIENT'S SHOULDER. THUS, THE SURGEON COULD NOT IMPLANT AND FIX THE ANCHOR. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM, ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO INFORMATION OF SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. THIS REPORT IS FOR A BIOKNOTLESS ETHIBOND ANCHOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8540443 ↗
• MalfunctionJul 26, 2018Break; Break

  ON DEPLOYMENT OF BOTH ANCHORS, THE SUTURE LOOP SNAPPED. CHANGED TO SAME LIKE PRODUCT TO COMPLETE SURGERY. TWO MINUTE DELAY. NO AE TO PATIENT. ADDITIONAL INFORMATION FROM THE AFFILIATE WHEN THE SURGEON PLACED TENSION ON THE LEAD SUTURE THE LOOP OF THE BIOKNOTLESS ANCHOR SNAPPED. THE SURGEON CLAIMS THAT NOT MUCH TENSION WAS PLACED AND HE SUSPECTS THE LOOP OF THE ANCHOR WAS COMPROMISED AS THE ANCHOR WAS HAMMERED INTO THE DRILL HOLE. THE SURGEON DRILLED ADDITIONAL HOLES TO ACCOMMODATE THE ADDITIONAL ANCHORS. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54213.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7723262 ↗
• MalfunctionJul 26, 2018Break; Break

  ON DEPLOYMENT OF BOTH ANCHORS THE SUTURE LOOP SNAPPED. CHANGED TO SAME LIKE PRODUCT TO COMPLETE SURGERY. 2 MINUTE DELAY. NO AE TO PATIENT. ADDITIONAL INFORMATION FROM THE AFFILIATE WHEN THE SURGEON PLACED TENSION ON THE LEAD SUTURE THE LOOP OF THE BIOKNOTLESS ANCHOR SNAPPED. THE SURGEON CLAIMS THAT NOT MUCH TENSION WAS PLACED AND HE SUSPECTS THE LOOP OF THE ANCHOR WAS COMPROMISED AS THE ANCHOR WAS HAMMERED INTO THE DRILL HOLE. THE SURGEON DRILLED ADDITIONAL HOLES TO ACCOMMODATE THE ADDITIONAL ANCHORS. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54212.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7723261 ↗
• InjuryJun 1, 2018Break; Break

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING A SHOULDER PROCEDURE, THE INSERTER TIP ON THE CUSTOMER'S BIO KNOTLESS PLUS ANCHOR BROKE OFF. THE SALES REP WAS NOT PRESENT AT THE CASE AND WAS NOT TOLD IF THE FRAGMENT WAS REMOVED. THERE WERE NO PATIENT CONSEQUENCES. THE DEVICE IS BEING RETURNED.

  Patient problems: Foreign Body In Patient; Tissue Damage

  MAUDE report 7560624 ↗

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