QUICKANCHOR ETHIBOND TAPERCUT 212851Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705002405), received between Jul 9, 2018 and Jan 23, 2019 — classified as 8 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (K030995, 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE HAND, IT WAS OBSERVED THAT THE MINILOK QA+ #2-0 ETH V-5 W/BIT ANCHOR DEVICE BROKE. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT WITH A FIVE MINUTE DELAY. THE FACILITY DISCARDED THE DEVICE. 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 8271892 ↗
• MalfunctionJan 23, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S MINI LOK Q/A MALFUNCTIONED. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR DELAYS. NO FURTHER DETAILS WERE PROVIDED SINCE THE SALES REP WAS NOT PRESENT AT THE CASE. 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 8271525 ↗
• MalfunctionJan 17, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A FOOT OPERATION FOR A HAGLUND SYNDROME ON THE LEFT HEEL, IT WAS OBSERVED THAT THE MINILOK QA+ #2-0 ETH V-5 W/BIT ANCHOR DEVICE WAS TORN OUT OF THE BONE. ACCORDING TO THE REPORTER, THE DEVICE DID NOT STAY IN THE BONE. THE SURGERY CONTINUED WITH ANOTHER TECHNIQUES BUT WAS PROLONGED FOR 20 MINUTES APPROXIMATELY. 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 8258200 ↗
• MalfunctionJan 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE HAND, IT WAS OBSERVED THAT THE CUSTOMER'S MINILOK QUICK ANCHOR PLUS WITH 2/0 ETHIBOND WITH V-5 DEVICE PULLED OUT AFTER INSERTION. THE SALES REP STATED THAT THE SURGEON STATED THAT THE ANCHOR WAS FINE BUT HE BELIEVES THAT THE WRONG SIZE DRILL BIT WAS PACKAGED WITH THE ANCHOR. THE SALES REP STATED THAT THE SURGEON REMOVED THE ANCHOR WITH NO 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 OR DELAYS IN THE PROCEDURE. THE SALES REP COULD NOT PROVIDE THE BONE QUALITY OF THE PATIENT. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. 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 8253367 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED THE ANCHOR TORE AFTER PLACEMENT FROM THE PATIENT'S BONE. THE DIAGNOSIS WAS HAGLUND SYNDROME. THE PROCEDURE WAS COMPLETED WITH A LIKE PRODUCT. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54053.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762974 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED THE ANCHOR TORE AFTER PLACEMENT FROM THE PATIENT'S BONE. THE DIAGNOSIS WAS HAGLUND SYNDROME. THE PROCEDURE WAS COMPLETED WITH A LIKE PRODUCT. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54048.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762969 ↗
• MalfunctionJul 16, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR SUTURE DEVICE BROKE DURING USE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS 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 7691199 ↗
• MalfunctionJul 9, 2018Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem

  IT WAS REPORTED BY A SALES REPRESENTATIVE THAT DURING AN UNSPECIFIED SURGICAL OF THE THUMB, IT WAS OBSERVED THAT THE MINILOK QA PLUS DEVICE PULLED OUT WITH THE INSERTER. ACCORDING TO THE REPORT, THE SURGEON TRIED TO DEPLOY IT A SECOND TIME, BUT IT PULLED OUT WHILE SETTING THE ANCHOR. IT WAS REPORTED THAT THERE NO DELAYS IN THE SURGICAL PROCEDURE AS THE SURGEON USED ANOTHER MINI ANCHOR IN THE SAME BONE HOLE. THERE WAS PATIENT INVOLVEMENT. 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 7670951 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030995, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722