MINITAC 72202019Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010619013), received between Oct 12, 2017 and Jan 28, 2026 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 16, 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.

• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF SMALL JOINTS OF THE HAND PROCEDURE, THE SUTURE OF THE MINITAC 2.0 ULTRABRAID BROKE, RESULTING IN THE LOSS OF THE STITCHES WHEN TYING THE THREADS OF THE REPORTED DEVICE, WITHOUT APPLYING FORCE AND WITHOUT USING FORCEPS OR NEEDLE HOLDERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON AN ADDITIONAL BONE HOLE, LEAVING A VOID IN THE PATIENT. PATIENT IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24200346 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE SURGEON HAD JUST BEGUN TO TWIST THE MINITAC 2.0 SCREW WHEN IT BROKE ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122263 ↗
• MalfunctionJan 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A COLLATERAL LIGAMENT SURGERY, THE MINITAC'S ANCHOR CABLE WAS VERY HARD AND, WHEN IT WAS PULLED, THE ANCHOR CAME OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544230 ↗
• MalfunctionJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE MINITAC ANCHOR WAS PULLED OUT AFTER THE IMPLANTATION. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486526 ↗
• InjuryNov 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A HUMERUS FRACTURE SURGERY, AFTER THE MINITAC ULTRABRAID ANCHOR WAS IMPLANTED, THE SCREW WAS LOOSENED. THE DEVICE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH THE HELP OF TWEEZERS AND SUCTION. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN AN ADDITIONALLY DRILLED BONE HOLE, AND THERE WAS A VOID LEFT IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18192101 ↗
• MalfunctionAug 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE HANDLE WAS REMOVED AFTER SCREWING THE MINITAC ANCHOR INTO THE CANCELLOUS BONE OF THE DISTAL PHALANX OF THE FIRST TOE OF THE RIGHT FOOT, THE ANCHOR CAME OUT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472144 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 YEARS AFTER A SURGERY IN THE LEFT INDEX FINGER WERE A MINITAC WAS USED, THE PATIENT PRESENTED REDNESS AND PAIN. ANTIBIOTICS AND ANTI-INFLAMMATORIES WERE PRESCRIBED. THE EVENT WAS NOT RESOLVED AND THE PATIENT HAD INCREASED PAIN. THE EVENT WAS TREATED WITH SURGERY TO REMOVE THE SCREW, AS WELL AS THE BONE MARROW AROUND SINCE IT WAS FOUND TO BE INFECTED AND NECROTIC. THE PATIENT IS IN GOOD CONDITION NOW.

  Patient problems: Necrosis; Osteomyelitis; Pain; Post Operative Wound Infection

  MAUDE report 15929534 ↗
• InjuryMay 21, 2022Degraded; Degraded

  IT WAS REPORTED THAT DURING A METACARPAL OSTEOSYNTHESIS PROCEDURE, THE MINITAC ANCHOR WAS INTRODUCED INTO THE BONE, LIGAMENTORRHAPHY WAS PERFORMED, AT THE TIME OF TYING, THE SUTURES WERE WORN, THE SPECIALIST USED A NEEDLE HOLDER, AT NO TIME DID HE USE TWEEZERS THAT COULD DAMAGE THE SUTURE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY BY LEAVING WITHOUT ANCHORAGE, IT WAS REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466504 ↗
• InjuryJul 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A WRIST TFCC REPAIR SCOPE USING THE MINITAC, THE FIRST ULTRABRAID ANCHOR WAS DISLODGED FROM THE BONE AND THE SECOND SUTURE ANCHOR DID NOT DEPLOY. NO SIGNIFICANT DELAY AND THE PROCEDURE WAS COMPLETED BY PUTTING INTO A 19G NEEDLE, THEREAFTER, THE SURGEON PIERCE THE TENDON USING THE NEEDLE AND IT PASSED THE SUTURE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249277 ↗
• InjuryJun 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE SURGERY, THE ANCHOR WAS BROKEN. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE IN THE SAME BONE HOLE. THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968586 ↗
• InjuryFeb 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE MNITAC 2.0 TITANIUM NEDDLES BENT AND BROKE WHILE TRYING TO PASS THE SUTURE. THEY CUT THE SUTURE AND USED A FREE NEEDLE. NO DELAY WAS REPORTED. 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 11283738 ↗
• InjuryJan 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE MINITAC 2.0 TITANIUM ANCHOR BROKE WHILE INSERTING IT IN THE PATIENT DURING AN ARTHROSCOPY. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE, NO 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 11158296 ↗
• MalfunctionSep 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A MAXILLOFACIAL REPAIR SURGERY, AFTER THE DEVICE WAS IMPLANTED, THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086634 ↗
• MalfunctionJun 17, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A WRIST SCOPE KIV TFCC REPAIR, WHEN THE SUTURES WERE BEING USED TO TIE OVER THE TENDONS, THE ANCHOR CAME OUT COMPLETELY FROM THE OPERATION SITE. SUTURES WERE REMOVED FROM THE PATIENT AND ANOTHER ANCHOR WAS INSERTED. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED. THE BACK UP DEVICE WAS USED IN A DIFFERENT HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704547 ↗
• MalfunctionSep 18, 2018Device Slipped

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW FELL OUT WHEN IMPLANTING. NO PATIENT INJURY WAS REPORTED. BACK-UP DEVICE WAS USE TO COMPLETED THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886110 ↗
• MalfunctionOct 12, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER INSERTING THE ANCHOR IT WAS TESTED FOR PULLOUT STRENGTH BY SURGEON AND IT CAME OUT. SURGEON RESORTED TO USING COMPETITORS ANCHOR TO COMPLETE REPAIR. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6946633 ↗