MICROFIX QUICKANCHOR ORTHOCORD 212045Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886705001903), received between Aug 14, 2018 and Jul 28, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

5 other recalls cover devices cleared under the same FDA submission (K032078, K080352, 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Postoperative purulent discharge & suture rejection. It was reported that the patient underwent surgery in (B)(6) 2024 to implant the device. After surgery, the patient exhibited purulent discharge, and the suture was rejected from the root of nail. The suture appears white to the naked eye. The surgeon stated that it could not be confirmed whether the discharge suture was the implanted device in previous surgery. The patient underwent surgery to remove some of the discharge suture last year.

  Patient problems: Purulent Discharge

  MAUDE report 50059369 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY SURGERY, IN THE WRIST JOINT MIRROR THE MICROFIX QUICKANCHOR ORTHOCORD DEVICE BROKE OFF. ALL BROKEN PARTS WERE REMOVED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315146 ↗
• MalfunctionMay 12, 2026Break

  THIS IS 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GRYPHON P BR DS ANCHOR W/OC DEVICE AND SUTURE DEVICE WERE BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGE TO ANOTHER DEVICE TO CONTINUE THE SURGERY, WHEN TIGHTENED THE SUTURE WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153859 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE MICRIFXQA+ W/#4OC C1 ANCHOR DEVICE WAS BROKEN. ALL THE BROKEN PIECES WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807667 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SURGERY, A MICROFIX QUICKANCHOR ORTHOCORD ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER MICROFIX QUICKANCHOR ORTHOCORD TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. A THIRD DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763664 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SURGERY, A MICROFIX QUICKANCHOR ORTHOCORD ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER MICROFIX QUICKANCHOR ORTHOCORD TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. A THIRD DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763599 ↗
• MalfunctionJul 24, 2025Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  IT WAS REPORTED THAT DURING A HAND SURGERY PROCEDURE, UPON OPENING THE PACKAGING OF THE MICRIFXQA+ W/#4OC C1 DEVICE, IT WAS FOUND THAT THE ANCHOR WAS DEFORMED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS STRIPPED/WORN/TWISTED/CROSS THREADED. 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 22591252 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE HAND IT WAS OBSERVED THAT THE SUTURE OF THE MICRIFXQA+ W/#4OC C1 DEVICE BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070772 ↗
• MalfunctionMay 15, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A HAND SURGICAL PROCEDURE THE MICRIFXQA+ W/#4OC C1 DEVICE ANCHOR PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030642 ↗
• MalfunctionMar 19, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A HAND SURGERY, IT WAS DISCOVERED THAT THE ANCHOR ON THE MICRIFXQA+ W/#4OC C1 DEVICE PULLED OUT WHILE THE SURGEON WAS PERFORMING THE FLIP FIXATION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED 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 21642988 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP FROM CHINA THAT DURING A SURGICAL PROCEDURE ON A FINGER ON (B)(6) 2023 THE 2X MICRIFXQA DEVICE WAS TIGHTENED THE SUTURE BROKE OFF. A DIFFERENT DEVICE WAS USED BUT THE SAME ISSUE OCCURRED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274974 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP FROM CHINA THAT DURING A SURGICAL PROCEDURE ON A FINGER ON (B)(6) 2023 THE 2X MICRIFXQA DEVICE WAS TIGHTENED THE SUTURE BROKE OFF. A DIFFERENT DEVICE WAS USED BUT THE SAME ISSUE OCCURRED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274966 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT THROUGH HEALTH AUTHORITY THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MICROFIX QA+ #4/0 OCORD C-1 W/BIT DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. 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 17839436 ↗
• MalfunctionMar 31, 2023Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  THIS IS 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MICROFIX QA+ #4/0 OCORD C-1 W/BIT ANCHOR DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR WAS DETACHED FROM THE INSERTER TIP ON THE DEVICE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657333 ↗
• MalfunctionFeb 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE HAD DETACHED FROM THE MICROFIX QA+ #4/0 OCORD C-1 W/BIT ANCHOR DEVICE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16307633 ↗
• MalfunctionJan 6, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  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 MICROFIX QA+ #4/0 OCORD C-1 W/BIT DEVICE WAS ALREADY BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR IS DETACHED FROM THE INSERTER TIP ON DEVICE. IT WAS FURTHER DETERMINED THAT BIOLOGICAL MATTER COULD BE OBSERVED INSIDE THE ANCHOR HOLE; AND THE INSERTER PIN THAT HOLDS THE ANCHOR WAS BENT. 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 16113569 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE MICRIFXQA+ W/#4OC C1 ANCHOR DEVICE WAS BROKEN. 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 12821576 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: DURING EXTENSOR TENDON REPAIR, AS THE DOCTOR WENT TO INSERT THE ANCHOR THE SHAFT ATTACHING THE ANCHOR TO THE INSERTER BROKE OFF. THE SURGERY WAS COMPLETED WITH ANOTHER ANCHOR. THE DEVICE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED FRAGMENTS WERE GENERATED BUT ALL PIECES WERE RECOVERED. THERE WAS A 5 MINUTE SURGICAL DELAY BUT NO COMPLICATION TO THE PATIENT WAS REPORTED. IT WAS ALSO STATED THAT THE DEVICE WAS DISCARDED BY THE FACILITY AND CANNOT BE RETURNED FOR AN EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10814379 ↗
• MalfunctionJan 15, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA FAX THAT DURING AN IMPLANTATION THE MICRIFXQA+ W/#4OC C1 WAS BROKEN. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593232 ↗
• MalfunctionSep 11, 2019Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED FROM (B)(6) THAT AT PRE-SURGERY, IT WAS OBSERVED THAT THE CAP ON THE MICRIFXQA+ W/#4OC C1 WAS FOUND DETACHED FROM THE ROD. IT WAS FURTHER REPORTED THAT THE ROD TIP WAS BENT WHEN THE DEVICE WAS RETRIEVED FROM THE PACKAGE. THE INCIDENT DID NOT CAUSE A DELAY IN THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BE BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8994986 ↗
• MalfunctionNov 27, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT MICRIFXQA+ W/#4OC C1 ANCHOR DEVICE DID NOT FIX TO THE BONE THAT IT PULLED OUT. ACCORDING TO THE REPORTER, THE ANCHOR DEVICE WAS NOT FIXED TO THE CORTICAL (THUMB P1). A SECOND ANCHOR WAS PLACED IN PLACE OF THE FIRST ONE TO COMPLETE THE PROCEDURE. 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 8107808 ↗
• MalfunctionSep 4, 2018Break; Break

  IT WAS REPORTED THAT THE CARTILAGE TRANSPLANT PROCEDURE TOOK PLACE AND ONE (1) MICROFIX QUICKANCHOR ORTHOCORD (#4 ORTHOCORD C1) ANCHOR WAS IMPLANTED AS THE SECOND ANCHOR WAS BEING PUT IN IT BROKE. THE SALES REP REPORTED THAT A 3RD ANCHOR WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844212 ↗
• MalfunctionAug 14, 2018Break; Break

  THE CUSTOMER FACILITY REPORTED VIA PHONE CALL THAT THEIR MICROFIX QA PLUS WITH ORTHOCORD FAILED DURING A BROW LIFT PROCEDURE. THE DEVICE TESTED FINE THEN ONCE IN USE THE PHYSICIAN WENT TO TIE THE SUTURE AND PULLED THE CORD AND IT BROKE. NO BONE HOLES AND NO NEW BONE HOLES CREATED. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE AS THIS DEVICE WAS REMOVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7781475 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032078, K080352, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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
• 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-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-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