TACIT QUICKANCHOR ETHIBOND TAPERCUT 212036Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705001842), received between Mar 19, 2018 and Apr 13, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA EMAIL WITH TACIT QA #2/0 ETH V5, USING THE TACIT ANCHOR BREAKS THE SUTURE. THERE WAS NO HARM TO THE PATIENT OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THIS EVENT WAS ALSO REPORTED BY ANOTHER J&J EMPLOYEE. ADDITIONAL EVENT DETAILS WERE REPORTED BY THE AFFILIATE AND STATED: "THE EVENT OCCURRED DURING A PROCEDURE FOR THE RECONSTRUCTION OF THE LIGAMENT. THE SURGEON WAS PASSING A STITCH WITH TACIT QUICKANCHOR 2.0 MINI ANCHOR REFERENCE, 212036, AND THE ANCHOR THREAD DISASSEMBLED. THE SALES REP REPORTED THE SUTURE COULD NOT BE PLACED IN THE ANCHOR. IT WAS REPORTED THE CASE WAS COMPLETED BY PASSING ANOTHER MINI ANCHOR AND IT WORKED VERY WELL AND DID NOT AFFECT THE PATIENT." THE AFFILIATE REPORTED THE DEVICE WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954333 ↗
• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING THE PROCEDURE THE SUTURE AND ANCHOR WERE BROKEN. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747887 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT UPON OPENING FROM ITS SEALED PACKAGING, THE ANCHOR TACIT 2.0 WAS IN BAD CONDITION WITH ITS BROKEN TIP AND THE PRODUCT COULD NOT BE USED IN SURGERY AND A NEW UNIT HAD TO BE OPENED. IT WAS NOT REPORTED IF 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: No Consequences Or Impact To Patient

  MAUDE report 9103792 ↗
• MalfunctionJan 28, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE AFFILIATE THAT THE SUTURE ON THE CUSTOMER'S TACIT QA ANCHOR AND MINILOK QA ANCHOR BROKE.

  Patient problems: Not Applicable

  MAUDE report 8281907 ↗
• MalfunctionJan 25, 2019Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A BROW LIFT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE BROKE ON THE TACIT QA #2/0 ETH V5+ HAND DRBT DEVICE. THERE WAS A FIVE-MINUTE DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE 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 8277898 ↗
• MalfunctionOct 30, 2018Material Frayed; Material Frayed

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE SUTURE ON THE CUSTOMER'S TACIT QA ANCHOR AND MINILOK QA ANCHOR BROKE WHILE IN USE TOGETHER. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. 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 8019153 ↗
• MalfunctionAug 6, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A LIP PROCEDURE, AT THE MOMENT THAT THE PHYSICIAN WAS PLACING THE ANCHOR, THE ANCHOR DID NOT STAY IN BONE OF THE PATIENT. WHEN THE PHYSICIAN WAS PULLING THE SUTURE ANCHOR FOR TO CHECK IF THE ANCHOR WAS STABLE INTO PATIENT´S BONE, THE ANCHOR LEAVES THE PATIENT´S BONE. THE DEVICE WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753978 ↗
• MalfunctionJul 17, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT TWO OF THE CUSTOMER'S TACIT QUICK ANCHORS PULLED OUT OF THE BONE HOLE DURING AN UNKNOWN PROCEDURE. HE STATED THE FIRST ANCHOR PULLED OUT WHILE THE SURGEON WAS TESTING THE SUTURE STRENGTH. HE TOOK THAT ANCHOR OUT AND USED ANOTHER ANCHOR IN THE SAME BONE HOLE WITH NO PROBLEM. IN ANOTHER BONE HOLE, A SECOND ANCHOR PULLED OUT WHILE THE SURGEON WAS TYING A KNOT WITH THE SUTURES. HE ALSO TOOK THAT ANCHOR OUT OF THE BONE HOLE AND INSERTED ANOTHER ANCHOR TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A 20 MINUTE DELAY AND BOTH ANCHORS WERE DISCARDED BY THE CUSTOMER. THE SALES REP WAS NOT SURE OF THE BONE QUALITY BUT STATED IT WAS A MALE IN HIS 50'S AND IT WAS NOT A REVISION SURGERY. NO FURTHER DETAILS WERE AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51323.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693840 ↗
• MalfunctionJul 17, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT TWO OF THE CUSTOMER'S TACIT QUICK ANCHORS PULLED OUT OF THE BONE HOLE DURING AN UNKNOWN PROCEDURE. HE STATED THE FIRST ANCHOR PULLED OUT WHILE THE SURGEON WAS TESTING THE SUTURE STRENGTH. HE TOOK THAT ANCHOR OUT AND USED ANOTHER ANCHOR IN THE SAME BONE HOLE WITH NO PROBLEM. IN ANOTHER BONE HOLE, A SECOND ANCHOR PULLED OUT WHILE THE SURGEON WAS TYING A KNOT WITH THE SUTURES. HE ALSO TOOK THAT ANCHOR OUT OF THE BONE HOLE AND INSERTED ANOTHER ANCHOR TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A 20 MINUTE DELAY AND BOTH ANCHORS WERE DISCARDED BY THE CUSTOMER. THE SALES REP WAS NOT SURE OF THE BONE QUALITY BUT STATED IT WAS A MALE IN HIS 50'S AND IT WAS NOT A REVISION SURGERY. NO FURTHER DETAILS WERE AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51324.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693839 ↗
• MalfunctionMar 19, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT IS USED IN TACIT 2.0MM MITEK ANCHOR SURGERY AND THE EXPECTED RESULT WAS NOT OBTAINED, DR. (B)(6) PERFORMED CORRECT TECHNIQUE, BONE PIERCING, RELEASE OF THE SUTURES OF THE INSERTER HANDLE AND WHEN CHECKING THE ANCHOR GRIP, IT IS FREES FROM THE CORTICAL BONE. RETRY THE INSERTION OF THE ANCHOR WITHOUT OBTAINING THE EXPECTED RESULT. SO HE DECIDED TO PLACE INPUT FROM ANOTHER PROVIDER WHICH IS FIXED IMMEDIATELY. THE EVENT LEAVES AS A CONSEQUENCE ONLY AN INPUT THAT WE CAN NOT CHARGE SINCE IT COULD NOT BE USED ON THE PATIENT. PATIENT RESOLVES HIS PROBLEM WITH AN ANCHOR FROM ANOTHER PROVIDER SO THERE ARE NO DELAYS IN THE SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7349327 ↗