MINITAC 72200795Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010585998), received between Jul 24, 2019 and Jan 19, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K972326); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2026Break

  IT WAS REPORTED THAT, APPROXIMATELY FOUR YEARS AFTER A PATIENT UNDERWENT A LUMBAR FUSION SURGERY, ONE OF THE MINITAC 2.0 DURABRAID SCREWS USED WAS FOUND FRACTURED INTERNALLY. ON (B)(6) 2025, A LUMBAR FUSION INTERNAL FIXATION REMOVAL SURGERY WAS PERFORMED, THE BROKEN SCREW WAS SUCCESSFULLY REMOVED, AND THE PATIENT WAS RETURNED TO THE WARD POSTOPERATIVELY. IT IS UNKNOWN IF THE BROKEN SCREW WAS REPLACED. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24109337 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE MINITAC DURABRAID SUTURE BROKE. THE SUTURE WAS REMOVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD USING THE ORIGINALLY BONE HOLE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846507 ↗
• InjuryMar 24, 2022Break; Break

  IT WAS REPORTED THAT ON A POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) REVIEW ¿CLINICAL ACTIVITY REPORT FOR KNEE DEVICES¿, 1 PATIENT HAD A BREAKAGE OF THE SUTURE LINE 4 MONTHS AFTER AN MCL PROCEDURE USING A MINITAC DEVICE. IT IS UNKNOWN HOW THE EVENT WAS TREATED. PATIENT OUTCOME IS UNKNOWN. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13880986 ↗
• InjuryDec 27, 2021Break; Break

  IT WAS REPORTED THAT DURING ACHILLES TENDON SURGERY, THE SUTURE OF THE MINITAC BROKE DURING SUTURING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087810 ↗
• InjuryApr 20, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A SURGERY IT WAS FOUND AN ORANGE FOREIGN MATERIAL INTO THE MINITAC DURABRAID STERILE PACKAGE. THE SAME ANCHOR WAS USED ON THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. NO COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692747 ↗
• InjuryMar 24, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE MINITAC DURABRAID ANCHOR SUTURE WAS BROKEN AFTER IT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566000 ↗
• InjuryMar 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER INSTABILITY REPAIR, THE MINITAC DURABRAID SUTURE BROKE AFTER IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478732 ↗
• InjuryJan 30, 2021Break; Break

  IT WAS REPORTED THAT DURING A REPAIR OF ANKLE LIGAMENT, THE MINITAC SUTURE BROKE AFTER THE ANCHOR WAS IMPLANTED. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11256336 ↗
• InjuryJun 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT AN ACHILES TENDON REPAIR WAS PERFORMED ON (B)(6) 2020; ON (B)(6) 2020 IT WAS FOUND THAT THE SUTURE SITE WAS BROKEN AND INFILTRATED, AS PER THIS ISSUE, ON (B)(6) 2020 A DEBRIMENT SUTURE REMOVAL WAS PERFORMED. NO DELAY WAS REPORTED AS THIS WAS FOUND AFTER THE SURGERY. MEDICAL INTERVENTION WAS REQUIRED TO REMOVED THE BROKEN SUTURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10151604 ↗
• MalfunctionApr 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A COLLATERAL LIGAMENT REPAIR SURGERY, THE SUTURE OF THE MINITAC SUTURE ANCHOR (2.0 TI) BROKE. THE ANCHOR STAYED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE INTO AN ADDITIONAL BONE HOLE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9963617 ↗
• MalfunctionJul 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A FINGER PROCEDURE, WHEN THE SURGEON INSERTED THE ANCHOR AND PULLED THE SUTURE, THE SUTURE FELL OFF THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE SO ANOTHER BONE HOLE WAS NECESSARY. NO PATIENT INJURY OR DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8822096 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972326. One submission often covers many models, so check the product and lot details in each record.

• Z-1273-2020 · Dec 30, 2019 · Terminated
  TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.