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QUICKANCHOR ETHIBOND 212867Recalls & reported problems

Depuy Mitek, LLC · MICRO QUICKANCHOR Plus (Number 4/0) Suture 4/0 (1.5 metric) white ETHIBOND braided polyester suture, with P-3 precision point needles and a 1.3 x 5.0mm drill bit · Class 2 · Implant

Adverse event reports
9
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705002542), received between Dec 19, 2018 and Jul 22, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

Most reported problems

Device problems

  • Break5
  • Difficult to Advance1
  • Difficult to Insert1
  • Difficult to Open or Close1
  • Entrapment of Device1
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient4
  • Injury1
  • Not Applicable1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 22, 2021Difficult to Advance; Difficult to Advance

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING AN UNKNOWN PROCEDURE ON (B)(4) 2021, IT WAS OBSERVED THAT THE MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND P-3 NEEDLES WOULD NOT STAY IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12213076 ↗
  • MalfunctionJun 18, 2021Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING A LATERAL CATHOPLASTY PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND P-3 NEEDLE DEVICE BROKE OFF. 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 12026773 ↗
  • MalfunctionJun 18, 2021Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021 , IT WAS OBSERVED THAT THE MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND P-3 NEEDLE DEVICE BROKE OFF. 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 12026764 ↗
  • MalfunctionFeb 19, 2021Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT THE MICRO QA+ #4/0 ETH P-3 DEVICE WAS BLOCKED. ACCORDING TO THE REPORT, THE SURGEON COULD NOT OPEN THE DEVICE WITH THE WHITE CORD EVEN WITH A HARD FORCE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAFT INSERTER ON THE DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11347945 ↗
  • InjuryNov 9, 2020Break; Entrapment of Device; Break; Entrapment of Device

    IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT WHEN THE MICRO QA+ #4/0 ETH P-3 ANCHOR WAS INSERTED (DURING A FOOT & ANKLE CASE), THE INSERTER CUT THROUGH THE SUTURES AND SO THE ANCHOR HAD TO BE LEFT IN THE BONE AND ANOTHER ONE WAS USED. IT WAS REPORTED IT DIDN¿T CAUSE ANY HARM TO THE PATIENT, BUT IT ADDED 10 MINUTES ONTO THE CASE. THE INSERTER CAN BE RETURNED, BUT THE ANCHOR IS IN THE PATIENT.

    Patient problems: Injury; Not Applicable

    MAUDE report 10814339 ↗
  • MalfunctionDec 3, 2019Break; Break

    IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT THE SURGEON WAS PUTTING IN A MICRO QUICKANCHOR PLUS FOR A NASAL VALVE SUSPENSION AND THE SUTURE ON THE ANCHOR BROKE. SHE HAD TO PLACE A SECOND ANCHOR AND THAT WAS SUCCESSFUL. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9406736 ↗
  • MalfunctionOct 23, 2019Use of Device Problem; Use of Device Problem

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, IT WAS REPORTED BY THE AFFILIATE VIA CST THAT THE MICRO QA+ #4/0 ETH P-3 WAS MISSING A TIP AND COULD THEREFORE NOT BE USED. THE FACILITY REQUIRES A REPLACEMENT UNIT. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MICRO QA+ #4/0 ETH P-3. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9226387 ↗
  • MalfunctionJan 17, 2019Difficult to Insert; Difficult to Insert

    IT WAS REPORTED BY THE SALES REP THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE OF THE WRIST, IT WAS OBSERVED THAT THE MICRO Q/A DEVICE FELL OFF OF THE INSERTER. THEY OPENED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CUSTOMER 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 8258616 ↗
  • MalfunctionDec 19, 2018Break; Break

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A THUMB REPAIR PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S MICRO QUICK ANCHOR+ WITH ETHIBOND SUTURE DEVICE BROKE WHILE INSERTING. THE CUSTOMER COULD NOT PROVIDE WHERE ON THE ANCHOR IT BROKE. THE CUSTOMER STATED THAT ALL DEBRIS WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAY. THE CUSTOMER STATED THAT NO SURGICAL INTERVENTION IS PLANNED. THE CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE ANCHOR IS BEING RETURNED FOR EVALUATION. 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 8179233 ↗

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.