QUICKANCHOR ORTHOCORD 212849Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886705002382), received between Aug 18, 2018 and Aug 5, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (7 reports).

5 other recalls cover devices cleared under the same FDA submission (K071257, K150209, K992487); 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.

• MalfunctionAug 5, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144578 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNKNOWN SURGERY WITH A MINILOK QA+#0 OC OS-2 DEVICE, THE SUTURE DETACHED FROM ANCHOR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 10 MIN DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE WAS NOT AVAILABLE FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015555 ↗
• MalfunctionJan 23, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MINILOK QA+#0 OC OS-2 DEVICE PULLED OUT. 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 21216380 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER A REVIEW OF CLINICAL DATASET RECEIVED FROM EQUIPE ZORGBEDRIJVEN NEDERLAND B.V. ON CLINICAL OUTCOMES AND COMPLICATIONS AFTER REINSERTION OF THE TRIANGULAR FIBROCARTILAGOUS COMPLEX (TFCC) USING THE MITEK® MINILOK QUICKANCHOR PLUS ANCHOR WITH ORTHOCORD SUTURE. COMPLICATIONS: THREE CASES OF RECURRENT DISTAL RADIOULNAR JOINT INSTABILITY (3%) WERE SCORED AS POSSIBLY RELATED TO THE BONE ANCHOR WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20894198 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Material Deformation; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR ON THE DEVICE WAS DETACHED FROM THE INSERTER TIP. IT WAS FURTHER DETERMINED THAT THE DISTAL END OF THE INSERTER ON THE DEVICE WAS SLIGHTLY DEFORMED. 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 16673567 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Material Deformation; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR ON THE DEVICE WAS DETACHED FROM THE INSERTER TIP. IT WAS FURTHER DETERMINED THAT THE DISTAL END OF THE INSERTER ON THE DEVICE WAS SLIGHTLY DEFORMED. 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 16673542 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TIP OF THE HANDLE ON THE MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT 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 16657084 ↗
• MalfunctionMar 31, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT DEVICE COULD NOT FIXED INTO THE BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657029 ↗
• MalfunctionJan 26, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE (B)(6) 2023, IT WAS OBSERVED THAT THE MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT DEVICE COULD NOT FIX INTO THE BONE. 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 16246927 ↗
• MalfunctionJan 26, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE (B)(6) 2023, IT WAS OBSERVED THAT THE MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT DEVICE COULD NOT FIX INTO THE BONE. 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 16246900 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN PROCEDURE (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE ON THE MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT DEVICE BROKE. 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 16246871 ↗
• MalfunctionNov 15, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA HAT DURING AN UNKNOWN PROCEDURE OF THE ANKLE ON (B)(6) 2022, IT WAS OBSERVED THAT THE MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT ANCHOR DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799576 ↗
• MalfunctionJun 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN ANKLE PERONEAL LIGAMENT STABILIZATION SURGICAL PROCEDURE USING MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT DEVICE ON AN UNKNOWN DATE, THE FIRST ANCHOR DEPLOYED SUCCESSFULLY HOWEVER, THE SECOND ANCHOR WOULD NOT DEPLOY. IT WAS REPORTED THAT THE ANCHOR KEPT PULLING OUT WHEN THE SURGEON REMOVED THE ANCHOR INSERTER. IT WAS REPORTED THAT 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 14686809 ↗
• MalfunctionJan 27, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE MINILOK QA+#0 OC OS-2 ANCHOR DEVICE FELL OFF OF THE INSERTER BEFORE IT WAS INSERTED ALL THE WAY. ACCORDING TO THE REPORT, THE SURGEON TRIED TO MAKE EACH WORK BUT THE ANCHORS WOULD NOT PROPERLY SEAT. 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 13369625 ↗
• MalfunctionJan 27, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE MINILOK QA0 OC OS-2 ANCHOR DEVICE FELL OFF OF THE INSERTER BEFORE IT WAS INSERTED ALL THE WAY. ACCORDING TO THE REPORT, THE SURGEON TRIED TO MAKE EACH WORK BUT THE ANCHORS WOULD NOT PROPERLY SEAT. 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 13369605 ↗
• MalfunctionJun 22, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A HAND SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE MINILOK QA+#0 OC OS-2 ANCHOR DEVICE WAS NOT FIXED PROPERLY. 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 12040300 ↗
• MalfunctionJun 16, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A HAND SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE MINILOK QA+#0 OC OS-2 ANCHOR DEVICE WAS NOT FIXED PROPERLY. 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 12011080 ↗
• MalfunctionDec 1, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A HAND SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT A MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE WITH NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928616 ↗
• MalfunctionJan 22, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  T WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL, THAT DURING AN UNKNOWN PROCEDURE, WHEN THE NURSE TOOK OUT A MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT, THE ANCHOR WAS SEPARATED FROM THE BODY. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9619104 ↗
• MalfunctionJan 22, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL, THAT DURING AN UNKNOWN PROCEDURE, WHILE USING A MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT, THE ANCHOR WAS NOT ISOLATED FROM THE BODY. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9618594 ↗
• MalfunctionNov 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE SUTURE IN MINILOK HAD ALREADY COME OUT OF THE PRODUCT WHEN THE SURGEON OPENED IT. ANOTHER ONE WAS USED AND THE PRODUCT WAS DISCARDED. THIS REPORT IS FOR A MINILOK QA+#0 OC OS-2. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9385783 ↗
• MalfunctionOct 30, 2018Material Frayed; Material Frayed

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE SUTURE ON THE CUSTOMER'S TACIT QA ANCHOR AND MINILOK QA ANCHOR BROKE WHILE IN USE TOGETHER. 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 A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. 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; Not Applicable

  MAUDE report 8019159 ↗
• MalfunctionAug 18, 2018Material Twisted/Bent; Material Twisted/Bent

  THE ANCHOR WAS DEFECTIVE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 5-11-2017: TYPE OF PROCEDURE WAS HAND SURGERY. THE HARPOON TIP WAS TWISTED WHEN IT WAS OPENED. THE PROCEDURE WAS COMPLETED WITH A NEW ONE. THERE WERE NO DELAYS. THERE WERE NO PATIENT CONSEQUENCES. THE DEVICE IS NOT COMING BACK FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795906 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071257, K150209, K992487. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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