TWINFIX 72202618Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03596010656131), received between Sep 7, 2017 and Mar 10, 2026 — classified as 16 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A SMALL JOINT ARTHROSCOPY, ONE (1) TWIN-FIX ULTRA SUTURE ANCHOR DID NOT ENTER THE BONE CORRECTLY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE BY INSERTING THE TENDON WITH TRANSOSSEOUS TUNNELS. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24559670 ↗
• MalfunctionJan 8, 2026Break; Material Frayed; Failure to Advance

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE TWINFIX ULTRA TI 5.5MM THREADS GOT TANGLED AROUND THE EDGES OF THE SCREW, AND IT WAS NOT POSSIBLE TO PERFORM THE STITCH. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. A VISUAL INSPECTION OF THE DEVICE REVEALED ONE SUTURE FRAYED AND FRACTURED AT THE PROXIMAL END OF THE ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010033 ↗
• MalfunctionMay 29, 2025Failure to Advance; Failure to Advance

  DURING AN ARTHROSCOPIC PROCEDURE, TWO (2) TWINFIX ULTRA 5.5MM ANCHORS FAILED IN THE SAME MANNER. THE FIRST ANCHOR ONLY INSERTED HALFWAY, AT WHICH POINT THE ANCHOR HANDLE DETACHED, AND THE SUTURES WERE DAMAGED. AS A RESULT, IT WAS DECIDED TO FULLY REMOVE THE ANCHOR USING PLIERS. THE SECOND ANCHOR WAS ALSO REMOVED AFTER IT WAS OBSERVED THAT IT HAD ONLY INSERTED HALFWAY. A 2.5MM DRILL WAS USED. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A TWINFIX 5.5 DRILL AND AN S+N ANCHOR IN THE ORIGINALLY DRILLED BONE HOLE, ALTHOUGH WITH DIFFICULTY, AS THE SURGEON NOTED THAT THE HANDLE WAS VERY WEAK AND BENT EASILY. THERE WAS A DELAY OF MORE THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102716 ↗
• MalfunctionMar 6, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, WHEN PASSING THE TWINFIX ULTRA SUTURE ANCHOR THROUGH THE BONE, THE SCREWDRIVER ROLLED OVER THE HEAD OF THE ANCHOR, PREVENTING ITS FULL ENTRY. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES, AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT'S HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 21533518 ↗
• MalfunctionFeb 25, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN THE TWINFIX ANCHOR WAS PLACED , IT RESISTED, AN ATTEMPT WAS MADE TO REMOVE IT BUT THE BLUE SUTURES BROKE. THE ANCHOR WAS REMOVED WITH PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINAL DRILLED BONE HOLE. THE PATIENT'S HEALTH CONDITION IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462151 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ULTRA UBRAID SUTURES BROKE WHEN THE ANCHOR WAS INTRODUCED. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646186 ↗
• InjuryJun 11, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX IMPLANT WAS INCORRECTLY ATTACHED TO THE GUIDE. IT WENT OFF AFTER OPENING. NO SURGICAL DELAY WAS REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, HOWEVER, A NEW BONE HOLE WAS USED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19510933 ↗
• MalfunctionMay 30, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SURGEON LOCATED THE TWINFIX ULTRA, IT IMPACTED A LITTLE WITH THE HAMMER AND BEGAN TO INSERT THE ANCHOR. WHEN HE WAS FINISHING ENTERING, THE SCREWDRIVER PART BROKE. THE ANCHOR WAS REMOVED WITH PLIERS FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19431959 ↗
• InjuryApr 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A TWINFIX ULTRA ANCHOR WAS DAMAGED DURING SCREWING AND THE SUTURES BROKE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681552 ↗
• InjuryApr 3, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, TWO (2) TWINFIX ULTRA ANCHORS WERE DAMAGED DURING SCREWING AND THE SUTURES BROKE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665935 ↗
• InjuryAug 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SPECIALIST REQUESTED TWO 5.5 MM TITANIUM ANCHORS, THE PROCEDURE WAS STARTED WITH ONE (1) TWINFIX ULTRA 5.5MM AND IT WAS OBSERVED THAT ONE OF THE THREADS OF THE ANCHOR WAS OUTSIDE, THE IMPLANT WAS NOT THREADING INTO THE CORTEX OF THE BONE, THE SPECIALIST DECIDED TO INTRODUCE THE STEM BACK INTO THE ANCHOR AND TRY TO TURN IT TO CONTINUE THREADING, BUT IT WAS NOT POSSIBLE, FOR THIS REASON THE SECOND ANCHOR WAS PASSED TO FINISH THE PROCEDURE, BUT IT WAS NECESSARY TO DRILLED AN ADDITIONAL HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT´S HEALTH CONDITION IS STABLE.

  Patient problems: Rupture

  MAUDE report 15253685 ↗
• InjuryApr 26, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING USE IN A COLLATERAL LIGAMENT REPAIR, WHEN INSERTING THE TWINFIX ANCHOR IN THE HOLE, THE HANDLE WAS DAMAGED AND DID NOT LET THE SCREW ROTATE SO THAT THE IMPLANT ENTERED CORRECTLY, LEAVING THE IMPLANT IN THE MIDDLE OF THE PATH, IT WAS REMOVED, IT WAS STARTED AGAIN AND A SECOND ATTEMPT WAS MADE BUT IT FAILED AGAIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209364 ↗
• InjuryApr 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT IN A PATELLAR LIGAMENT REPAIR PROCEDURE, THE SPECIALIST USED A 5.5 TWINFIX ANCHOR, WHICH FAILED AFTER THE TIME OF IMPLANTATION. THE DOCTOR PREVIOUSLY STARTED WITH A 3.2 DRILL BIT FOR THE PLACEMENT OF THE ANCHOR, BUT WHEN INTRODUCING THE ANCHOR, THE DOCTOR FORCED HIMSELF TO REACH THE TOP OF THE LASER LINE AND WHEN REMOVING THE HANDLE, IT CAME OUT WITH SUTURES, WHICH MAKE THE TWINFIX 5.5 NON-FUNCTIONAL, THE DOCTOR QUICKLY REMOVED THE TWINFIX FROM THE PATIENT. THE DOCTOR DECIDED TO SOLVE THIS FAILURE AND COMPLETE THE PROCEDURE BY PLACING TWO MORE OF THE SAME TWINFIX ANCHORS. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088224 ↗
• InjuryFeb 11, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE TWINFIX ULTRABRAID ANCHOR BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A SURGICAL DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518174 ↗
• InjuryAug 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER DRILLING WITH A 3.8 MM DRILL BIT, THE DEVICE WAS IMPLANTED, WHEN HALF OF THE ANCHOR IMPLANT WAS CARRIED, IT BEGAN TO ROTATE ON ITS AXIS WITHOUT VISUALIZATION OF THE SCREW ENTRY, PRESENTING RUPTURE OF THE SUTURE THREADS. A REVERSE EXTRACTION SCREW WAS USED AND THE IMPLANT WAS EXTRACTED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297615 ↗
• InjuryJun 14, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE IN A SHOULDER ARTHROSCOPY, THE TIP WAS IMPACTED, WHEN THE ANCHOR WAS INTRODUCED INTO THE BONE, THE TIP OF THE HANDLE WAS ROLLED, THAT IS, IT ROTATED BETWEEN THE ANCHOR AND DID NOT PUSH IT SO THAT IT COULD BE INSERTED, WHICH CAUSED HALF OF THE ANCHOR TO BE LEFT OUT. THE IMPLANT WAS REMOVED WITH PLIERS. A DELAY GREATER THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996897 ↗
• InjuryApr 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING ROTATOR CUFF TENDON REPAIR, THE ANCHOR CAME OUT FROM BONE HOLE WHEN TYING THE SUTURES, THE ANCHOR WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH NEEDLE SUTURES, FIXING THE TENDON TO THE BONE. NO ADDITIONAL BONE HOLES WERE REQUIRED. 20 MINUTES OF DELAY OCCURRED. 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 11676129 ↗
• InjuryMar 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROXIMAL HAMSTRING REPAIR, THE TWINFIX ANCHORS BROKE OFF WHILE ADVANCING. THE ANCHORS WERE REMOVED WITH A SCREW SET AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 10 MINUTES USING A S&N FOOTPRINT. 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 11478740 ↗
• InjuryMar 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROXIMAL HAMSTRING REPAIR, THE TWINFIX ANCHORS BROKE OFF WHILE ADVANCING. THE ANCHORS WERE REMOVED WITH A SCREW SET AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 10 MINUTES USING A S&N FOOTPRINT. 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 11478739 ↗
• InjuryFeb 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TWINFIX ULTRA 2 UBRAID AND NDLS 5.5MM TITANIUM FAILED DURING IMPLANTATION. AT THE MOMENT OF IMPACTING IT A FEW TIMES THE ANCHOR ENTERED THE PATIENT'S BONE. HOWEVER, THE AREA WAS SO STRONG THAT WHEN IT WAS SCREWED IN, THE ANCHOR HANDLE BEGAN TO COLLAPSE, DEFORMED. THIS PROCEDURE COULD BE COMPLETED USING AN ABSORBABLE SYNTHETIC SUTURE CALLED VICRYL. PATIENT'S HEALTH IS STABLE. NO SIGNIFICANT DELAY OR FURTHER 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 11289326 ↗
• InjuryDec 17, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, AT THE TIME OF INSERTING THE TWINFIX ULTRA 5.5 IMPLANT, IT DETACHED FROM THE HANDLE IN WHICH IT CAME AND BENT WHEN TRYING TO RE-PASS IT. THE SUBSTITUTIONS THAT CAME WITH IT BROKE AND THE ENTIRE IMPLANT WAS DETACHED, LEAVING IT USELESS. IN ADDITION, ONE OF THE SUTURES OF THE NEEDLES DISINSERTED THE THREAD. THE PIECES OF THIS IMPLANT WERE REMOVED AND ANOTHER TWINFIX WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. NO SIGNIFICANT DELAY AND NO DAMAGE CAUSED. 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 11030020 ↗
• InjuryOct 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE ANCHOR OF THE TWINFIX FAILED AT THE TIME OF PLACING IN THE PATELLA. THE PROPER PRACTICE OF PLACING THE ANCHOR WAS FOLLOWED BUT IT REMAINED OUTSIDE THE PATELLA AND ADDITIONAL MANEUVERS HAD TO BE PERFORMED TO FINISH INSERTING IT SINCE THE INSERTION HANDLE WAS ROLLED AND DID NOT CONTINUE TO INSERT THE ANCHOR, SO IT WAS OUTSIDE THE PATELLA. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE USING ADDITIONAL TOOLS. NO SIGNIFICANT DELAY AND NO PATIENT 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 Information

  MAUDE report 10681278 ↗
• InjuryJun 10, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING SURGERY, THE DR. HAMMERED UP MORE THAN HALF OF THE "TWINFIX ULTRA TITANIUM ANCHOR", THEN HE TURNED IT AND THE HANDLE WAS ROLLED. HOWEVER, IT WAS NOTICED THE ANCHOR DID NOT ENTER ITS ENTIRETY IN THE BONE. IN CONSEQUENCE, THE DR. PROCEEDED TO REMOVE THE ANCHOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY BY PLACING ANOTHER ANCHOR OF THE SAME REFERENCE. 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: Injury

  MAUDE report 10140264 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN INSTABILITY SURGERY, THE SURGEON HAD A HARD TIME SETTING THE ANCHOR, THE ANCHOR WAS BROKEN WHEN IT WAS BEING INSERTED INTO THE BONE. THE PHYSICIAN STATED THAT THE BONE WAS A BIT HARD, THEREFORE, THE DEVICE BROKE OFF. A DELAY GREATER THAN 30 MINUTES WERE REPORTED DUE TO DEVICE MALFUNCTION. THE SURGEON CHANGED FROM ARTHROSCOPIC TO OPEN IN ORDER TO REMOVE THE ANCHOR FROM THE PATIENT¿S ANATOMY. SURGERY WAS COMPLETED USING A BACK-UP DEVICE. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9514291 ↗
• MalfunctionAug 16, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, WHILE TRYING TO PUT A BONE TRANSECTION POINT, THE TWINFIX NEEDLE WAS STUCK; WHEN ATTEMPTING TO REMOVE IT, THE SUTURE DETACHED FROM THE NEEDLE. IN CONSEQUENCE, THE PHYSICIAN DECIDED TO LEAVE THE NEEDLE INSIDE OF THE PATIENT. IT IS UNKNOWN IF/HOW THE PROCEDURE WAS FINISHED. THE SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8900831 ↗