TACIT QUICKANCHOR ETHIBOND TAPERCUT 212236Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705002023), received between Jul 11, 2018 and Mar 2, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN PROCEDURE AFTER DRILLING WITH THE ACCOMPANYING DRILL BIT, WHEN THE SURGEON USED, THE THREAD OF THE TACIT QA #2/0ETH V5 WAS DETACHED FROM THE ANCHOR BODY. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE DEVICE WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9777185 ↗
• MalfunctionDec 5, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY AFFILIATE THAT DURING AN UNKNOWN PROCEDURE OUT OF THE 5 TACIT QA #2/0ETH V5 THAT WERE USED IN THE PROCEDURE. THE SUTURES OF TWO OF THE TACIT QA #2/0ETH V5 LOOKED VERY LOOSE AND ALSO THEY WERE HARD TO DEPLOY. NO PATIENT CONSEQUENCE WAS REPORTED. HOWEVER, THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. THE AFFILIATE LATER REPORTED THE DEVICES WILL NOT RETURNED FOR INVESTIGATION AND ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9419329 ↗
• MalfunctionDec 5, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY AFFILIATE THAT DURING AN UNKNOWN PROCEDURE OUT OF THE 5 TACIT QA #2/0ETH V5 THAT WERE USED IN THE PROCEDURE. THE SUTURES OF TWO OF THE TACIT QA #2/0ETH V5 LOOKED VERY LOOSE AND ALSO THEY WERE HARD TO DEPLOY. NO PATIENT CONSEQUENCE WAS REPORTED. HOWEVER, THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. THE AFFILIATE LATER REPORTED THE DEVICES WILL NOT RETURNED FOR INVESTIGATION AND ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9418715 ↗
• MalfunctionMay 30, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING THE LIFT UP SURGERY, IT WAS OBSERVED THAT THE TACIT QUICK ANCHOR WAS IMPLANTED INTO THE PATIENT'S BODY. AFTER THE SUTURE WAS ATTACHED WITH THE ANCHOR, AND WHILE CLOSING, IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT ALL THREADS WERE BROKEN. THE SURGEON REMOVED THE ANCHOR AND IMPLANTED AN ALTERNATIVE ANCHOR INTO THE SAME POSITION TO COMPLETE THE SURGERY. THERE WAS APPROXIMATELY A FIFTEEN MINUTE SURGICAL DELAY AND NO HARM TO THE PATIENT WAS REPORTED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 8655594 ↗
• MalfunctionSep 3, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED PLASTIC SURGERY, IT WAS OBSERVED THAT THE TACIT QUICK ANCHOR #2/0, W/V-5 DEVICE WAS LOOSE AND CAME OFF FROM THE BONE HOLE AFTER INSERTION. ANOTHER ANCHOR WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL 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 7840864 ↗
• MalfunctionJul 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP THAT DURING A BROW LIFT THAT THE CUSTOMER'S TACIT QUICK ANCHOR PULLED OUT AFTER IT WAS INITIALLY INSERTED. THE SALES REP REPORTED THE SURGEON PREPPED THE BONE HOLE, AND HAD JUST INSERTED THE ANCHOR WHEN IT CAME RIGHT OUT. THE ANCHOR WAS OFF THE INSERTER AT THE TIME. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES AND A 5 MINUTE DELAY. THE CUSTOMER ALREADY DISCARDED THE ANCHOR. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7677532 ↗