MICROFIX QUICKANCHOR ORTHOCORD 212044Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886705001897), received between Feb 7, 2019 and Apr 22, 2026 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE THE MICRIFXQA+ W/#4OC (ORTHOCORD) P3 ANCHOR DETACHED FROM ITS SUTURES AFTER HAVING ALREADY BEEN PLACED IN THE BONE. THE ANCHOR REMAINED EMBEDDED IN THE BONE, BUT THE DISC WAS SUTURED USING A DIFFERENT METHOD. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH, THE SURGERY WAS COMPLETED. A PART OF THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951574 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component; Component Misassembled

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MICRIFXQA+ W/#4OC P3 DEVICE FELL APART. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE COULD NOT BE ASSEMBLED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 24377947 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X MICRIFXQA+ W/#4OC P3 DEVICE MOTOR WAS GOING TO BE USED TO PLACE THE MICROFIX ANCHOR, BUT THE MOTOR DID NOT HAVE ENOUGH POWER. WHEN DRILLING, IT WAS NOT DRILLED DEEP ENOUGH, AND WHEN THE ANCHOR WAS INSERTED IT BROKE. THERE WAS A DELAY IN THE SURGERY BECAUSE THE USER HAD TWO UNITS OF EACH ANCHOR TYPE, BUT ALREADY USED ONE ON THE RIGHT SIDE, AND NEEDED THE OTHER FOR THE LEFT, SO1.3MM MICRO QUICK ANCHOR DEVICE WAS USED THIS WAY AND IT WAS RESOLVED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935291 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X MICRIFXQA+ W/#4OC P3 DEVICE MOTOR WAS GOING TO BE USED TO PLACE THE MICROFIX ANCHOR, BUT THE MOTOR DID NOT HAVE ENOUGH POWER. WHEN DRILLING, IT WAS NOT DRILLED DEEP ENOUGH, AND WHEN THE ANCHOR WAS INSERTED IT BROKE. THERE WAS A DELAY IN THE SURGERY BECAUSE THE USER HAD TWO UNITS OF EACH ANCHOR TYPE, BUT ALREADY USED ONE ON THE RIGHT SIDE, AND NEEDED THE OTHER FOR THE LEFT, SO1.3MM MICRO QUICK ANCHOR DEVICE WAS USED THIS WAY AND IT WAS RESOLVED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935285 ↗
• MalfunctionAug 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE OF TEMPOROMANDIBULAR ARTHRECTOMY + MENISCUSITIS + BILATERAL CONDYLENTOLIA, AT THE TIME THE SPECIALIST WAS PREPARING TO USE THE MICROFIX QUICKSNCHOR ANCHOR AND WHEN POSITIONING IT FOR USE, IT WAS EVIDENT THAT THE TIP OF THIS WAS DEFECTIVE (BENT), WHICH IS WHY IT WAS NOT POSSIBLE TO USE SAID REFERENCE, SO THE SPECIALIST REQUESTED TO OPEN ANOTHER ANCHOR OF THE SAME REFERENCE AND CHARACTERISTICS, WHICH COULD BE USED WITHOUT ANY PROBLEM, THUS SUCCESSFULLY COMPLETING THE SURGERY, WITHOUT DISCOMFORT TO THE SPECIALIST, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN SURGICAL TIMES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786673 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MICRIFXQA+ W/#4OC P3 DEVICE BROKE OFF DURING USE. ACCORDING TO THE REPORTER, THE DOCTOR PROPERLY CREATED A DRILL HOLE, BUT WHILE INSERTING THE DEVICE, THE TIP BROKE OFF, RENDERING IT UNUSABLE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628513 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MINI ANCHOR ON THE MICRIFXQA+ W/ # 4OC P3 DEVICE FAILED WHEN UTILIZED, RESULTING IN THE SUTURE BREAKING. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 22035819 ↗
• MalfunctionNov 29, 2023Migration; Migration

  IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 USING THE MICRIFXQA+ W/4OC P3 DEVICE, THE SURGEON DID THE BROCADE TO THE TOP WITHOUT NOVELTY, THE MINI ANCHOR WAS PASSED, THEN HE INTRODUCED IT INTO THE CHANNEL, THE BAG OF ITS PACKAGING AND BEGAN TO SUTURE IT AT THE TIME OF KNOTTING IT THE MINI ANCHOR WENT OUT OF THE PLACE. THE SURGEON DECIDED TO LEAVE THE DEVICE IN THE PATIENT BECAUSE THE FUNCTION COULD BE FULFILLED WITHOUT BEING IN THE CHANNEL. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233830 ↗
• MalfunctionNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 IT WAS OBSERVED THAT AT THE MOMENT THE SPECIALIST WAS TYING THE POINTS HE MADE, THE PART OF THE MICROFIX QA+ #4/0 OCORD P-3 W/BIT DEVICE ANCHOR WHERE HE REINSERTS IT WITH A DISSECTING FORCEPS CAME OUT AND THE DOCTOR CONTINUED TYING. IT WAS REPORTED THAT HE HAD TO MAKE SOME DIFFERENT KNOTS AND POINTS SO THAT THE ANCHOR DID NOT COME OFF. 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 18083007 ↗
• MalfunctionDec 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING A LIGAMENT ORRHAPHY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURE ON THE MICROFIX QA+ #4/0 OCORD P-3 W/BIT DEVICE WAS RELEASED AND REINSERTED INTO THE ANCHOR ALREADY IN PLACE IN THE PATIENT. 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 16045387 ↗
• MalfunctionNov 24, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE MICROFIX QA+ #4/0 OCORD P-3 W/BIT DEVICE DID NOT HAVE THE STARTER. 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 15863626 ↗
• InjuryJan 6, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT POSTOPERATIVELY ON (B)(6) 2021 DURING BANDAGING OF THE FIXATION FROM AN UNKNOWN SURGERY INITIALLY PERFORMED ON (B)(6) 2021, IT WAS DETECTED THROUGH X-RAY THAT THERE WERE INSOLVENCIES OF FIXATION USING THE MICRIFXQA+ W/#4OC P3 ANCHOR DEVICE AS THE THREAD LOST ITS INTEGRITY. ACCORDING TO THE REPORT, THE SECOND OPERATION WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE BROKEN SUTURE BUT THE ANCHOR COULD NOT BE REMOVED AND IT REMAINED IN THE PATIENT. THE STATUS OF THE PATIENT WAS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13177959 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ORTHOPEDIC SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE EDGE ON THE MICRIFXQA+ W/#4OC P3 ANCHOR DEVICE SPLIT WHEN OPENING AND PLACING IT. 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 13027714 ↗
• MalfunctionNov 19, 2021Break; Device Damaged Prior to Use; Contamination /Decontamination Problem; Break; Device Damaged Prior to Use; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE MICRIFXQA+ W/#4OC P3 ANCHOR DEVICE WAS DEFECTIVE UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE INSERTER TIP WAS BROKEN; AND BOTH THE ANCHOR AND SUTURE ON THE DEVICE WERE IMPREGNATED WITH BIOLOGICAL MATTER. 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 12846372 ↗
• MalfunctionOct 26, 2021Use of Device Problem; Residue After Decontamination; Material Split, Cut or Torn; Use of Device Problem; Residue After Decontamination; Material Split, Cut or Torn

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE THREAD ON THE DEVICE SKIPPED WHEN THE SURGEON WAS GOING TO FIX IT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUTURE WAS BROKEN FROM THE PART THAT HELD THE ANCHOR. IT WAS FURTHER DETERMINED THAT THE DEVICE WAS IMPREGNATED WITH RESTS OF BIOLOGICAL MATTER. 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 12698631 ↗
• MalfunctionJul 7, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE MICRIFXQA+ W/#4OC P3 ANCHOR DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128545 ↗
• MalfunctionDec 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LIGAMENTOPLASTY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT WHEN THE SUTURE WAS PULLED, THE ANCHOR DEVICE CAME OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11079708 ↗
• InjuryOct 10, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE AFFILIATE THE ANCHORS BREAK AND REMAIN INSIDE THE PATIENT THE SUTURE HAS BURST AND DID NOT WORK.

  Patient problems: Foreign Body In Patient; Injury; Not Applicable

  MAUDE report 10659938 ↗
• MalfunctionDec 26, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE WHEN THE SURGEON WAS STRAINING THE THREADS AS INDICATED BY THE SURGICAL TECHNIQUE, THE MICRIFXQA+ W/#4OC P3 CAME OFF AND WHEN CHECKING IT WAS NOTED THAT IT 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 9521980 ↗
• MalfunctionFeb 7, 2019Break; Break

  AT THE MOMENT TO PLACE THE ANCHOR, THE ANCHOR WAS BROKEN DURING A HAND PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM THE AFFILIATE ON 2-24-16. THE ANCHOR DID BREAK DURING THE INSERTION. THE ANCHOR WAS REPLACED FOR OTHER TO COMPLETE THE PROCEDURE THE ORIGINAL BONE HOLE USED TO COMPLETE THE PROCEDURE. THE SURGERY DID NOT EXTEND 30 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318934 ↗

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-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-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