QUICKANCHOR ETHIBOND 212032Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886705001804), received between Jul 10, 2018 and Dec 30, 2020 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A TENDON REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE THREAD ON THE ANCHOR DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096520 ↗
• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A TENDON REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE THREAD ON THE ANCHOR DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096498 ↗
• MalfunctionSep 24, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE TREATING ACROMIOCLAVICULAR JOINT DISLOCATION PERFORMED ON (B)(6)2020. BEFORE THE STERILIZED PACKAGE OF THE ANCHOR WAS UNSEALED, A HAIR WAS FOUND INSIDE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10584101 ↗
• MalfunctionJan 2, 2020Break; Break

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL VIA FAX, THAT DURING AN UNKNOWN PROCEDURE, A SUPER QUICKANCHOR® PLUS #2, SINGLE PACK, GOT BROKEN DURING INSTALLATION. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE SALES REPRESENTATIVE BELIEVES THE INCIDENT IS RELATED TO IMPROPER DEVICE HANDLING AND NOT THE QUALITY OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539445 ↗
• InjuryApr 15, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE 2 WIRES WERE STRIPPED AND THEN BROKE WITHOUT EXCESSIVE TRACTION. A SECOND ANCHOR WAS USED IN A LIMITED SPACE BECAUSE IT WAS IMPOSSIBLE TO REMOVE THE BROKEN ANCHOR.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8514924 ↗
• MalfunctionJan 24, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE LEG AND ANKLE REPAIR, IT WAS OBSERVED THAT THE SUPER QA+ #2 ETH CP-2 *EA DEVICE WAS BENT WHEN IT WAS OPENED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE 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 8274124 ↗
• MalfunctionJan 18, 2019Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUPER QA+ #2 ETH CP-2 *EA SUTURE DEVICE TORE DURING KNOTTING. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE 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 8261975 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE SUPER QA+ #2 ETH CP-2 *EA DEVICE HAD A PLACEMENT FAILURE THAT IT BROKE DURING USE. 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. 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 8260260 ↗
• MalfunctionNov 16, 2018Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE GREEN BRAIDED SUTURE ON TWO OF THEIR SUPER QUICK ANCHORS, PLUS 2 ETHIBOND, C-P 2 NEEDLE BROKE WHEN TYING THE KNOT. THE CUSTOMER REPORTED THAT THE SURGEON WAS NOT PULLING TO HARD BUT HAD NO FURTHER INFORMATION. THE CUSTOMER ALREADY DISCARDED THE DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8079025 ↗
• MalfunctionNov 13, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTS THAT DURING AN UNKNOWN PROCEDURE, THE WIRE OF THE ANCHOR FRAYED AND BROKE DURING ITS USE. THE SURGEON USED ANOTHER ANCHOR WITH THE SAME LOT NUMBER: THE SAME PROBLEM OCCURRED. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY WITH A THIRD ANCHOR OF A NEW LOT ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON (B)(6) 2019 STATING THE NAME OF THE SURGEON, A SURGICAL DELAY OF TEN (10) MINUTES OCCURRED DURING THE PROCEDURE, AND PATIENT DEMOGRAPHICS. THE ADDITIONAL INFORMATION ALSO STATED THAT THERE HAS BEEN NO IMPACT TO THE PATIENT OUTCOME OR RECOVERY. IT WAS ALSO STATED THAT ALL FRAGMENTS OF THE BROKEN DEVICE WERE REMOVED AND THE SURGERY WAS COMPLETED TO THE PREFERRED TREATMENT.

  Patient problems: Not Applicable

  MAUDE report 8065761 ↗
• MalfunctionNov 13, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTS THAT DURING AN UNKNOWN PROCEDURE, THE WIRE OF THE ANCHOR FRAYED AND BROKE DURING ITS USE. THE SURGEON USED ANOTHER ANCHOR WITH THE SAME LOT NUMBER: THE SAME PROBLEM OCCURRED. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY WITH A THIRD ANCHOR OF A NEW LOT. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON (B)(6) 2019 STATING THE NAME OF THE SURGEON, A SURGICAL DELAY OF TEN (10) MINUTES OCCURRED DURING THE PROCEDURE, AND PATIENT DEMOGRAPHICS. THE ADDITIONAL INFORMATION ALSO STATED THAT THERE HAS BEEN NO IMPACT TO THE PATIENT OUTCOME OR RECOVERY. IT WAS ALSO STATED THAT ALL FRAGMENTS OF THE BROKEN DEVICE WERE REMOVED AND THE SURGERY WAS COMPLETED TO THE PREFERRED TREATMENT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8065756 ↗
• InjuryAug 8, 2018Break; Break

  IT WAS REPORTED BY THE CUSTOMER USING MITEK SUPER ANCHORS IN SURGERY LAST WEEK THAT THE ANCHOR SUTURES HAD BROKEN OFF EXCEPTIONALLY EASILY IN 4 ANCHORS. THIS HAS NOT HAPPENED IN THE PAST. THERE WAS PATIENT CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED ON 7/12/2018 SURGEON HAD PERFORMED OPEN HAMSTRING OPERATION TO A PATIENT. THE ANCHOR SUTURES HAD BROKEN OFF EXCEPTIONALLY EASILY IN 4 ANCHORS. THIS RESULTED THAT SURGEON HAD TO APPLY 2 MORE DIFFERENT ANCHORS, SO THERE IS MORE METAL ANCHORS IN PATIENT COMPARED TO NORMAL. ALSO THE SURGERY WAS DELAYED. THIS PATIENT WAS OPERATED LAST WEEK, SO THE HEALING OF THE PATIENT REMAINS TO BE SEEN. THE PRODUCTS ARE NOT AVAILABLE BECAUSE THE SUTURES WERE DISCARDED AND THE METAL PARTS WERE LEFT TO PATIENT.

  Patient problems: Foreign Body In Patient; Tissue Damage

  MAUDE report 7765870 ↗
• InjuryAug 8, 2018Break; Break

  IT WAS REPORTED BY THE CUSTOMER USING MITEK SUPER ANCHORS IN SURGERY LAST WEEK THAT THE ANCHOR SUTURES HAD BROKEN OFF EXCEPTIONALLY EASILY IN 4 ANCHORS. THIS HAS NOT HAPPENED IN THE PAST. THERE WAS PATIENT CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED ON 7/12/2018: SURGEON HAD PERFORMED OPEN HAMSTRING OPERATION TO A PATIENT. THE ANCHOR SUTURES HAD BROKEN OFF EXCEPTIONALLY EASILY IN 4 ANCHORS. THIS RESULTED THAT SURGEON HAD TO APPLY 2 MORE DIFFERENT ANCHORS, SO THERE IS MORE METAL ANCHORS IN PATIENT COMPARED TO NORMAL. ALSO THE SURGERY WAS DELAYED. THIS PATIENT WAS OPERATED LAST WEEK, SO THE HEALING OF THE PATIENT REMAINS TO BE SEEN. THE PRODUCTS ARE NOT AVAILABLE BECAUSE THE SUTURES WERE DISCARDED AND THE METAL PARTS WERE LEFT TO PATIENT.

  Patient problems: Foreign Body In Patient; Tissue Damage

  MAUDE report 7765866 ↗
• InjuryAug 8, 2018Break; Break

  IT WAS REPORTED BY THE CUSTOMER USING MITEK SUPER ANCHORS IN SURGERY LAST WEEK THAT THE ANCHOR SUTURES HAD BROKEN OFF EXCEPTIONALLY EASILY IN 4 ANCHORS. THIS HAS NOT HAPPENED IN THE PAST. THERE WAS PATIENT CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED ON 7/12/2018: SURGEON HAD PERFORMED OPEN HAMSTRING OPERATION TO A PATIENT. THE ANCHOR SUTURES HAD BROKEN OFF EXCEPTIONALLY EASILY IN 4 ANCHORS. THIS RESULTED THAT SURGEON HAD TO APPLY 2 MORE DIFFERENT ANCHORS, SO THERE IS MORE METAL ANCHORS IN PATIENT COMPARED TO NORMAL. ALSO THE SURGERY WAS DELAYED. THIS PATIENT WAS OPERATED LAST WEEK, SO THE HEALING OF THE PATIENT REMAINS TO BE SEEN. THE PRODUCTS ARE NOT AVAILABLE BECAUSE THE SUTURES WERE DISCARDED AND THE METAL PARTS WERE LEFT TO PATIENT.

  Patient problems: Foreign Body In Patient; Tissue Damage

  MAUDE report 7765864 ↗
• InjuryAug 8, 2018Break; Break

  IT WAS REPORTED BY THE CUSTOMER USING MITEK SUPER ANCHORS IN SURGERY LAST WEEK THAT THE ANCHOR SUTURES HAD BROKEN OFF EXCEPTIONALLY EASILY IN 4 ANCHORS. THIS HAS NOT HAPPENED IN THE PAST. THERE WAS PATIENT CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED ON 7/12/2018: SURGEON HAD PERFORMED OPEN HAMSTRING OPERATION TO A PATIENT. THE ANCHOR SUTURES HAD BROKEN OFF EXCEPTIONALLY EASILY IN 4 ANCHORS. THIS RESULTED THAT SURGEON HAD TO APPLY 2 MORE DIFFERENT ANCHORS, SO THERE IS MORE METAL ANCHORS IN PATIENT COMPARED TO NORMAL. ALSO THE SURGERY WAS DELAYED. THIS PATIENT WAS OPERATED LAST WEEK, SO THE HEALING OF THE PATIENT REMAINS TO BE SEEN. THE PRODUCTS ARE NOT AVAILABLE BECAUSE THE SUTURES WERE DISCARDED AND THE METAL PARTS WERE LEFT TO PATIENT.

  Patient problems: Foreign Body In Patient; Tissue Damage

  MAUDE report 7765863 ↗
• MalfunctionJul 10, 2018Break; Break

  THE PURCHASING AGENT FOR (B)(6) HOSPITAL REPORTED THAT ONE OF THE SUTURES ON THEIR SUPER QUICK ANCHOR BROKE PROXIMAL TO THE ANCHOR. SHE COULD NOT PROVIDE MORE INFORMATION BUT WAS ABLE TO CONFIRM THERE WERE NO PATIENT CONSEQUENCES OR DELAY IN THE PROCEDURE DUE TO THE DEVICE'S FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673181 ↗