QUICKANCHOR ORTHOCORD 222984Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10886705008629), received between May 15, 2018 and May 13, 2026 — classified as 10 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (25 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. 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Device Contaminated During Manufacture or Shipping

  CUSTOMER REPORTED THERE WERE RED SPOTS ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163991 ↗
• MalfunctionApr 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SUTURES OF 2X SUPER QA+ O/C DS CP DEVICES DETACHED FROM THE NEEDLE WITHOUT ANY RESISTANCE. IT WAS REPORTED THAT ON ONE OF THE DEVICES, THE THREAD ALSO SNAPPED DESPITE NO SHARP OBJECTS BEING NEARBY. IT WAS REPORTED THAT BOTH INCIDENTS OCCURRED DURING THE SAME PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035588 ↗
• MalfunctionApr 29, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SUTURES OF 2X SUPER QA+ O/C DS CP DEVICES DETACHED FROM THE NEEDLE WITHOUT ANY RESISTANCE. IT WAS REPORTED THAT ON ONE OF THE DEVICES, THE THREAD ALSO SNAPPED DESPITE NO SHARP OBJECTS BEING NEARBY. IT WAS REPORTED THAT BOTH INCIDENTS OCCURRED DURING THE SAME PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035581 ↗
• MalfunctionMay 19, 2025Break; Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE SUPER QA+ O/C DS CP-2 *EA DEVICE THE ORTHOCORD SUTURE BROKE WHEN PULLING TO MAKE A KNOT. IT WAS UNKNOWN IF THERE WERE DELAYS IN THE PROCEDURE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044577 ↗
• MalfunctionMay 19, 2025Break; Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE SUPER QA+ O/C DS CP-2 *EA DEVICE THE ORTHOCORD SUTURE BROKE WHEN PULLING TO MAKE A KNOT. IT WAS UNKNOWN IF THERE WERE DELAYS IN THE PROCEDURE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044575 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUPER QA+ O/C DS CP-2 *EA DEVICE BROKE WHEN THE SURGEON PULLED ON THE SUTURES OF THE ANCHOR. ACCORDING TO THE REPORT, THE SURGEON FIRST HAD TROUBLE SLIDING THE OPENING TO RELEASE THE WIRES FROM THE ANCHOR, AND THEN WHEN HE PULLED THE WIRES, THE ANCHOR WAS TORN OFF THE BONE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463676 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THROUGH A POST MARKET STUDY THAT A PATIENT HAD UNDERGONE A ROTATOR CUFF REPAIR PROCEDURE WITH BICEPS TENODESIS AND SUPRA + SUBSCAPULARIS REPAIR ON (B)(6) 2024, USING TWO 4.75 HEALIX ADVANCE KNTLS BR DEVICES AND ONE SUPER QA+ O/C DS CP-2 DEVICE. ACCORDING TO THE REPORT, A POST OPERATIVE FALL OCCURRED RESULTING IN ANATOMIC NECK FRACTURE OF THE PROXIMAL HUMERUS AND A RETEAR OF THE ROTATOR CUFF. IT WAS REPORTED THAT THIS HAD ULTIMATELY APPEARED TO HAVE HEALED BUT A REVERSE SHOULDER ARTHROPLASTY PROCEDURE WAS NEEDED AND PERFORMED ON (B)(6) 2024. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20440591 ↗
• MalfunctionFeb 26, 2024Break; Break

  THIS IS REPORT 5 OF 6 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING THE TENSIONING OF A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT FIVE GII QUICK ANCHOR PLUS SIZE 2 (5 METRIC) ORTHOCORD BRAIDED COMPOSITE SUTURE DEVICES BROKE, AND THE ANCHOR FROM THE SUPER QUICKANCHOR DEVICE REMAINED EMBEDDED UNDER THE CORTEX. THERE WAS NO PROBLEM DURING IMPACTION. THERE WAS A TWENTY-TO-THIRTY-MINUTE DELAY IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777630 ↗
• MalfunctionJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP FROM GERMANY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE SUPER QA DEVICE HAD LOOSENED THE THREADS FROM THE NEEDLES. IT LOOKED AS IF THE THREADS WERE NOT GLUED PROPERLY IN THE NEEDLES. THE CUSTOMER THEN SIMPLY USED A SINGLE NEEDLE (SPRING-EYE NEEDLE) AND FINISHED THE OPERATION WITH THE ANCHOR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE CUSTOMER USED THE REMAINING ANCHORS WITH THE SOLDER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546081 ↗
• MalfunctionJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP FROM GERMANY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE SUPER QA DEVICE HAD LOOSENED THE THREADS FROM THE NEEDLES. IT LOOKED AS IF THE THREADS WERE NOT GLUED PROPERLY IN THE NEEDLES. THE CUSTOMER THEN SIMPLY USED A SINGLE NEEDLE (SPRING-EYE NEEDLE) AND FINISHED THE OPERATION WITH THE ANCHOR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE CUSTOMER USED THE REMAINING ANCHORS WITH THE SOLDER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545954 ↗
• MalfunctionJul 11, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ORTHOCORD ON TWO SUPER QUICKANCHOR+ DS W/#2 ORTHOCORD DEVICES BROKE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17301608 ↗
• MalfunctionJul 11, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ORTHOCORD ON TWO SUPER QUICKANCHOR+ DS W/#2 ORTHOCORD DEVICES BROKE. 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 17301573 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE BROKE AFTER INSERTING THE ANCHOR ON THE SUPER QUICKANCHOR+ DS W/#2 ORTHOCORD DEVICE. 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 14288310 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUPER QA+ O/C DS CP-2 DEVICE BROKE EVEN WHEN IT WAS HANDLED CORRECTLY. 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 13995726 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUPER QA+ O/C DS CP-2 DEVICE BROKE EVEN WHEN IT WAS HANDLED CORRECTLY. 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 13995714 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN SWITZERLAND THAT DURING AN ELBOW SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE BROKE IN THE SUPER QA+ O/C DS CP-2 DEVICE BROKE WHEN PLACED IN 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 13713541 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN SWITZERLAND THAT DURING AN ELBOW SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE BROKE IN THE SUPER QA+ O/C DS CP-2 DEVICE BROKE WHEN PLACED IN 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 13713382 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ELBOW SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE BROKE IN THE SUPER QA+ O/C DS CP-2 DEVICE BROKE WHEN PLACED IN 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 13713377 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN ELBOW SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE BROKE IN THE SUPER QA+ O/C DS CP-2 DEVICE BROKE WHEN PLACED IN 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 13713324 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ELBOW SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE BROKE IN THE SUPER QA+ O/C DS CP-2 DEVICE BROKE WHEN PLACED IN 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 13713300 ↗
• InjuryJan 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE CAME OFF THE ANCHOR ON THE SUPER QA+ O/C DS CP-2 DEVICE WITHOUT STRAINING. ACCORDING TO THE REPORT, THE SUTURE LOOKED FRAYED AND REPOSITIONING DID NOT HELP. THE ANCHOR WAS LEFT IN THE PATIENT. THERE WAS AN UNSPECIFIED DELAY IN THE SURGERY. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13206417 ↗
• InjuryJan 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE CAME OFF THE ANCHOR ON THE SUPER QA+ O/C DS CP-2 DEVICE WITHOUT STRAINING. ACCORDING TO THE REPORT, THE SUTURE LOOKED FRAYED AND REPOSITIONING DID NOT HELP. THE ANCHOR WAS LEFT IN THE PATIENT. THERE WAS AN UNSPECIFIED DELAY IN THE SURGERY. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13206344 ↗
• MalfunctionSep 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A LATERAL MALLEOLUS REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP OF THE HANDLE ON THE SUPER QUICKANCHOR+ DS W/#2 ORTHOCORD DEVICE WAS DAMAGED AND SLIGHTLY BENT WHEN IT WAS TAKEN OUT OF THE PACKAGING. IT WAS FURTHER REPORTED THAT THE ANCHOR WAS UNLATCHED FROM THE TIP ON THE HANDLE TO REPAIR THE EXTENSOR HALLUCIS LONGUS TENDON. IT WAS REPORTED THAT THE SURGEON HAD TO MAKE SOME ADJUSTMENTS FOR THE ANCHOR TO SIT PROPERLY AND MANAGED TO INSERT THE IMPLANT SUCCESSFULLY. THEY ONLY USED ONE ANCHOR SUTURE FOR THIS CASE. 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 12463281 ↗
• MalfunctionJun 28, 2021Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURE DEVICE WAS FRAYED. 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 12077853 ↗
• MalfunctionJun 28, 2021Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURE DEVICE WAS FRAYED. 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 12077807 ↗