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QUICKANCHOR ETHIBOND 212133Recalls & reported problems

Depuy Mitek, LLC · Mini QUICKANCHOR Plus (Number 0 Suture) Size 0 (3.5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with OS-2 needles, with disposable inserter. · Class 2 · Implant

Adverse event reports
17
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705001972), received between May 9, 2018 and Feb 19, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break8
  • Component Missing2
  • Failure to Advance2
  • Bent1
  • Device-Device Incompatibility1
  • Entrapment of Device1
  • Failure to Clean Adequately1
  • Material Twisted/Bent1

Patient problems

  • No Consequences Or Impact To Patient11
  • No Clinical Signs, Symptoms or Conditions4
  • Not Applicable3
  • Injury1
  • No Patient Involvement1

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 19, 2025Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT DURING A PERONEAL TENDON REPAIR PROCEDURE ON THE RIGHT LEG FOR A PERONEAL TENDON DISLOCATION, IT WAS DISCOVERED THAT THE ANCHOR ON THE MINI QA+ #0 ETH OS-2 HAD BECOME LOOSE. ACCORDING TO THE REPORTER, AFTER INSERTING THE DEVICE INTO THE BONY HOLE, THE SURGEON WAITED TEN SECONDS AND THEN WITHDREW IT ACCORDING TO THE PROCEDURE MANUAL. HOWEVER, THE ARC DID NOT RETURN TO ITS ARCHED SHAPE, AND THE ANCHOR BECAME LOOSE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21412943 ↗
  • MalfunctionSep 7, 2023Migration; Migration

    IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MINI QUICKANCHOR® PLUS #0, SINGLE PACK DEVICE CAME OFF AFTER INSERTION. 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 17701256 ↗
  • MalfunctionJul 14, 2023Break; Break

    IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE MINI QUICKANCHOR® PLUS #0, SINGLE PACK DEVICE WAS BROKEN. 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 17325670 ↗
  • MalfunctionOct 29, 2021Break; Device-Device Incompatibility; Failure to Clean Adequately; Break; Device-Device Incompatibility; Failure to Clean Adequately

    IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE A MINI QUICKANCHOR® PLUS #0, SINGLE PACK DID NOT DEPLOY PROPERLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 12723505 ↗
  • MalfunctionNov 10, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED BY THE SALES REP VIA PERSONAL INTERACTION THAT DURING AN UNKNOWN PROCEDURE AND AFTER DEPLOYING TWO ANCHORS, THE SURGEON INSERTED THE 3RD ANCHOR AND WHEN THE SUTURE WAS PULLED THE MINI QA+ #0 ETH OS-2 *EA CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE USING THE SAME BURR HOLE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICE WILL NOT RETURNED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10820338 ↗
  • MalfunctionNov 5, 2020Failure to Advance; Failure to Advance

    IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. ALTHOUGH THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE ON INSERTING THE ANCHOR INTO THE BURR HOLE, THE ANCHOR CAME OFF. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. 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 10795912 ↗
  • MalfunctionJun 29, 2020Component Missing; Component Missing

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE NEEDLE WAS MISSING INSIDE THE BOX WHICH PREVENTED THE PROCEDURE. 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 THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 10207268 ↗
  • MalfunctionJun 29, 2020Component Missing; Component Missing

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE NEEDLE WAS MISSING INSIDE THE BOX WHICH PREVENTED THE PROCEDURE. 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 THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 10207247 ↗
  • InjuryJun 29, 2020Break; Entrapment of Device; Break; Entrapment of Device

    IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING A HAND SURGERY, IT WAS OBSERVED THAT TWO ANCHORS FAILED. ON THE FIRST ANCHOR: THE INSERTER GOT BENT WHEN INSERTED AND COULDN'T BE USED SINCE THE ANCHOR LOOSENED FROM INSERTER. ON THE SECOND ANCHOR: THE SUTURE BROKE AND THE ANCHOR WAS LEFT INSIDE THE PATIENT. SURGEON MENTIONED THAT THE SUTURE SLIDED POORLY IN ANCHOR. DRILLING WAS USED IN NORMAL WAY. SURGEON VERY EXPERIENCED IN USING THESE ANCHORS. SURGERY WAS DELAYED OF FIVE MINUTES. A THIRD ANCHOR WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: Injury; Not Applicable

    MAUDE report 10207128 ↗
  • MalfunctionJun 29, 2020Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A HAND SURGERY, IT WAS OBSERVED THAT TWO ANCHORS FAILED. ON THE FIRST ANCHOR: THE INSERTER GOT BENT WHEN INSERTED AND COULDN'T BE USED SINCE THE ANCHOR LOOSENED FROM INSERTER. ON THE SECOND ANCHOR: THE SUTURE BROKE AND THE ANCHOR WAS LEFT INSIDE THE PATIENT. SURGEON MENTIONED THAT THE SUTURE SLIDED POORLY IN ANCHOR. DRILLING WAS USED IN NORMAL WAY. SURGEON VERY EXPERIENCED IN USING THESE ANCHORS. SURGERY WAS DELAYED OF FIVE MINUTES. A THIRD ANCHOR WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: Not Applicable

    MAUDE report 10207113 ↗
  • MalfunctionDec 10, 2019Break; Break

    IT WAS REPORTED THAT DURING THE LATERAL MALLEOLUS LIGAMENT REPAIR SURGERY, WHEN TIED THE KNOT, THE SUTURE WAS BROKEN,REMOVED THE ANCHOR WITH 3-0 ABSORBABLE SUTURE TO REPLACE THE BROKEN SUTURE TO COMPLETE THE SURGERY. THE SURGERY DELAYED ABOUT 30 MINUTES. THE PATIENT IS STABLE AND IN HOSPITAL NOW.

    Patient problems: No Consequences Or Impact To Patient; No Patient Involvement; Not Applicable

    MAUDE report 9446801 ↗
  • MalfunctionJan 24, 2019Break; Break

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE SUTURE BROKE ON TWO OF THEIR MINI QUICKANCHOR PLUS #0 ETHIB WHEN TYING THE TISSUE DOWN DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE ANKLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS, THE CASE WAS COMPLETED WITH THE DEVICES, CONTINUING WITH THE SMALLER PORTION OF SUTURE THAT WAS LEFT. THE DEVICES ARE NOT BEING RETURNED AS THEY WERE USED TO COMPLETE 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 8275971 ↗
  • MalfunctionJan 24, 2019Break; Break

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE SUTURE BROKE ON TWO OF THEIR MINI QUICKANCHOR PLUS #0 ETHIB WHEN TYING THE TISSUE DOWN DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE ANKLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS, THE CASE WAS COMPLETED WITH THE DEVICES, CONTINUING WITH THE SMALLER PORTION OF SUTURE THAT WAS LEFT. THE DEVICES ARE NOT BEING RETURNED AS THEY WERE USED TO COMPLETE 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 8275969 ↗
  • MalfunctionOct 19, 2018Break; Break

    ADDITIONAL EVENT INFORMATION RECEIVED ON 10/21/2018. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7984765 ↗
  • MalfunctionAug 16, 2018Break; Break

    OUR AFFILIATE REPORTED THIS PATIENT HAD A FRACTURE OF THE DISTAL TIBIA WHICH WAS FIXATED WITH A 3.5 X 50 MM CANNULA. AN ANCHOR WAS INSTALLED AFTER OPENING THE CORTICAL WITH A DRILL BIT. THE SUTURE BROKE WHILE THE KNOT WAS BEING TIED, AND THE ANCHOR WAS PULLED OUT. AN ATTEMPT WAS MADE TO PASS THE SUTURE ALONE WITH THE NEEDLE, BUT IT BROKE LOSE AGAIN FROM THE NEEDLE ASSEMBLY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7788856 ↗
  • MalfunctionJul 9, 2018Positioning Problem; Positioning Problem

    IT WAS REPORTED BY A SALES REPRESENTATIVE THAT DURING A TEMPOROMANDIBULAR JOINT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON HIS MINI QUICK ANCHOR PLUS W/ETHIBOND WAS UNRAVELING AFTER THE SURGEON TIED THE KNOT. THERE WAS NO DELAY IN THE PROCEDURE. IT WAS REPORTED THE PROCEDURE WAS COMPLETED USING LEFT OVER SUTURE FROM THE KNOT, WRAPPING IT AROUND THE ANCHOR AND TYING ANOTHER KNOT TO REINFORCE IT. 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 WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7670782 ↗
  • MalfunctionMay 9, 2018Bent; Bent

    ANCHOR TIP BEND. IT WAS NOTED THAT TIP OF ANCHOR BENT WHEN OUT OF PACKAGE. CHANGED THE NEW ONE TO COMPLETE. THERE WAS NO ADVERSE EVENT ON PATIENT REPORT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7499845 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.