TWINFIX 7210708Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03596010532206), received between Aug 24, 2017 and Feb 12, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR PROCEDURE, IT WAS NOTICED THAT THE TWINFIX 5.0 ANCHOR'S TIP GOT BROKEN WHILE TAPPING IT INTO THE BONE. THE BROKEN PIECES WERE REMOVED WITH HELP OF A GRASPER. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON A NEW DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS GOOD AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24321928 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT DURING A KNEE LIGAMENTOPLAST PROCEDURE, FOUR ANCHOR WIRES OF THE TWIN-FIX TI ANCHOR BROKE AT THE BASE AFTER IMPLANTATION. THE ANCHOR WAS LEFT INSIDE THE PATIENT. ANOTHER ANCHOR WAS PLACED IN THE SAME BONE HOLE, LEAVING NO VOID IN THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, AFTER 2-3 MINUTE DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 24096686 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, IT WAS NOTICED THAT THE SUTURE OF THE TWINFIX ULTRA ANCHOR GOT CUT. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING THE SAME PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854930 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ANCHOR GOT BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120260 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ANCHOR BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079653 ↗
• MalfunctionJun 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TWINFIX ANCHOR COULD NOT ENGAGE IN THE PILOT HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153131 ↗
• MalfunctionDec 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN OPEN ROTATOR CUFF REPAIR OF THE RIGHT SHOULDER, DURING SUTURE MANIPULATION AND TYING, TWO NEEDLES OF THE TWINFIX ULTRABRAID ANCHOR FELL TO THE GROUND, THE NEEDLES BROKE OFF. SURGERY WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. PATIENT CURRENT STATUS IS HEALTHY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929400 ↗
• MalfunctionMay 15, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING A KNEE LIGAMENT REPAIR SURGERY USING THE TWINFIX ANCHOR, THE ANCHOR WITH SUTURE WAS SEPARATED WITH SUTURE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE WITH A DELAY GREATER THAN 30 MIN. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403982 ↗
• InjurySep 7, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING USE, THE TWINFIX GOT PULLED OUT FROM THE BONE SUTURE, ALSO, THE ANCHOR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436458 ↗
• InjuryJun 30, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, USING THE "TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N", THE TIP OF THE INSERTER WAS BROKEN WHEN THE ANCHOR WAS SCREWED TO THE BONE. ALL PIECES WERE REMOVED FROM THE PATIENT WITH THE ANCHOR ITSELF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094701 ↗
• InjuryJun 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE NEEDLE DETACHED FROM THE "5.0MM TWINFIX TI SUTURE ANCHOR". THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12079810 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER INTRODUCE THE ANCHOR OF THE TWINFIX (WHEN RETRIEVING THE THREADS WITH NEEDLES), 3 THREADS OUT OF 4 BECAME LOOSE RIGHT AWAY. THE ANCHOR WAS LEFT IN PLACE IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853295 ↗
• MalfunctionSep 27, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LIGAMENT REPAIR IN PROXIMAL HUMERUS, THE DEVICE WAS STRIPPED. BONE WAS ALREADY PRE-DRILLED, BUT THE DEVICE WAS STILL STRIPPED. THE DEVICE BROKE INSIDE THE PATIENT AND BROKEN PIECES WERE REMOVED WITH TWEEZERS AND PLIERS. THE BACK UP DEVICE WAS USED IN AN ADDITIONAL BONE HOLE AND THE PROCEDURE WAS COMPLETED WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9128193 ↗
• MalfunctionAug 14, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LIGAMENT REPAIR IN PROXIMAL HUMERUS, THE DEVICE WAS STRIPPED. BONE WAS ALREADY PRE-DRILLED, BUT THE DEVICE WAS STILL STRIPPED. THE DEVICE BROKE INSIDE THE PATIENT AND BROKEN PIECES WERE REMOVED WITH TWEEZERS AND PLIERS. THE BACK UP DEVICE WAS USED IN AN ADDITIONAL BONE HOLE AND THE PROCEDURE WAS COMPLETED WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8895830 ↗
• MalfunctionJul 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE CAME OUT OF THE BONE. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A BACKUP S&N DEVICE AFTER DRILLING AN ADDITIONAL HOLE. NO PATIENT INJURY OR SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8794543 ↗
• MalfunctionJul 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE CAME OUT OF THE BONE. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A BACKUP S&N DEVICE AFTER DRILLING AN ADDITIONAL HOLE . NO PATIENT INJURY OR SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8791761 ↗
• MalfunctionSep 11, 2018Break

  IT WAS REPORTED THAT THE SCREW WAS BROKEN INSIDE THE TIBIA BONE. NO DELAY NOR PATIENT INJURIES WERE REPORTED. A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7864819 ↗
• MalfunctionJun 29, 2018Break

  IT WAS REPORTED THAT THE TOP OF THE ANCHOR BROKE OFF. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652944 ↗
• MalfunctionApr 9, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT WHEN SURGEON INSERTED THE ANCHOR INTO THE BONE, DEPLOYED THE NEEDLES. ONLY 3 OF THE 4 SUTURE HAD NEEDLES ON. THE FOURTH NEEDLE BROKE OFF FROM THE SUTURE DURING DEPLOYMENT. SURGEON USED A CURVED MAYO NEEDLE FROM THE PHARMACY IN ORDER TO COMPLETE HIS SUTURING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7406267 ↗
• MalfunctionMar 24, 2018Break

  IT WAS REPORTED THAT ANCHOR WAS INSERTED INTO THE BONE AND WHEN THE NEEDLES WHERE DEPLOYED, IT WAS FOUND THAT ONLY 3 OF THE 4 SUTURE HAD NEEDLES ON AND THE THIRD ONE BROKE OFF FROM THE SUTURE DURING DEPLOYMENT. SURGEON USED AN CURVED MAYO NEEDLE FROM THE PHARMACY IN ORDER TO COMPLETE SUTURING. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7368645 ↗
• MalfunctionJan 16, 2018Break

  IT WAS REPORTED THAT WHILE USING THE TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N, THE FIRST ANCHOR WAS ENTERED IN THE BONE ON THE PATIENT¿S ANKLE WITHOUT PROBLEMS, BY THE SURGEON. THE SECOND ONE BROKE WHEN ENTERING THE BONE IN THE ANKLE. IT OCCURRED WHEN THE TIP OF THE ANCHOR WAS INSIDE THE PATIENT. THE TIP WAS LEFT INSIDE THE BONE IN THE PATIENT. THE SURGEON IS AN EXPERIENCED USER OF TWINFIX. NO PATIENT HARM OR DEATH. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7194232 ↗
• MalfunctionAug 24, 2017Sticking

  IT WAS REPORTED THAT THE ANCHOR DIDN'T MOVED WHILE HANDLE WAS MOVING, ANCHOR COULDN'T BE PLACED. TEAR WAS FIXED MANUALLY WITHOUT ANY DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816059 ↗

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.