MINITACRecalls & reported problems across all models
Smith & Nephew, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 2 models of MINITAC by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2017 and Jan 28, 2026 — classified as 15 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MINITAC problems
Device problems
- Break11
- Device Dislodged or Dislocated6
- Material Separation3
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Known Impact Or Consequence To Patient6
- Perforation2
- Injury1
- Insufficient Information1
- Necrosis1
- Osteomyelitis1
- Pain1
MINITAC models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MINITAC 72202019STAPLE, FIXATION, BONE16 reports
- MINITAC 72200795FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE11 reports
Recent MINITAC adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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