TWINFIX 7210707Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 03596010532190), received between Dec 27, 2017 and Apr 19, 2026 — classified as 17 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2026Difficult to Insert; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING SURGERY, THE TWISTING OF ONE (1) TWINFIX ANCHOR PREVENTED THE ANCHOR FROM BEING DRIVEN TO THE DESIRED PATH. IT WAS NEEDED TO DRILL A LARGE HOLE TO REMOVE THE ANCHOR. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS AN UNSPECIFIED DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24921354 ↗
• MalfunctionApr 14, 2026Difficult to Insert; Osseointegration Problem

  IT WAS REPORTED THAT DURING SURGERY, THE TWISTING OF ONE (1) TWINFIX ANCHOR PREVENTED THE ANCHOR FROM BEING DRIVEN TO THE DESIRED PATH. THERE WAS A RISK OF RESIDUAL PAIN AT THE SITE WHERE THE METAL PROTRUDED FROM THE BONE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876507 ↗
• MalfunctionFeb 3, 2026Fracture

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TWINFIX 3.5 SUTURE ANCHOR FRACTURED IN HALF WHEN IT WAS INSERTED IN THE BONE, THEY USED A 1.7 DRILL BIT TO PREVENT THE FRACTURE, BUT IT STILL OCCURRED. THE SUTURES OF THE ANCHOR CAME OUT OF THE PATIENT. THE ANCHOR WAS LEFT IN THE PATIENT'S BONE. THE PROCEDURE COULD NOT BE COMPLETED, AND NO OTHER SURGERY WAS PROGRAMMED. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24250952 ↗
• MalfunctionSep 2, 2025Fracture; Detachment of Device or Device Component; Material Twisted/Bent; Fracture; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TWINFIX 3.5 SUTURE ANCHORS FRACTURED IN HALF WHEN THEY WERE INSERTED IN THE BONE. THE SUTURES OF THE ANCHOR CAME OUT OF THE PATIENT. THE ANCHOR WAS LEFT IN THE PATIENT'S BONE. THE PROCEDURE COULD NOT BE COMPLETED, AND NO OTHER SURGERY WAS PROGRAMMED. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22935068 ↗
• InjuryJul 9, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT, DURING A SHOULDER JOINT REPAIR SURGERY, THE REMAINING ONE-THIRD OF A TWINFIX 3.5 MM ANCHOR COULD NOT BE IMPLANTED INTO THE CANCELLOUS BONE. FURTHER FORCE APPLIED CAUSED THE DISTAL END OF THE ANCHOR ROD TO TWIST. THE ANCHOR WAS LEFT IN THE BODY. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN AN ADDITIONALLY DRILLED BONE HOLE, THROUGH AN OPEN APPROACH. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 22459071 ↗
• MalfunctionMay 14, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT, DURING A DISTAL FIBULA FRACTURE SURGERY, WHEN THE TWINFIX TI 3.5 SUTURE ANCHOR WAS INSERTED, IT REACHED A CERTAIN POINT AND DID NOT CONTINUE ADVANCING, THE CORE OF THE ANCHOR WAS BENT. THE ANCHOR WAS REMOVED FROM THE PATIENT WITH A PLIERS AND WITH THE HELP OF A BROKEN SCREW EXTRACTOR. SURGERY WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE, A 2.5MM PIN AND 2.5MM DRILL BIT WERE USED AND THEN A 2.8MM ANCHOR. IT WAS NECESSARY TO DRILL AN ADDITIONAL BONE HOLE, AND THERE WAS A VOID LEFT IN THE PATIENT. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22019598 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE ON THE TWINFIX TI ANCHOR BROKE AFTER IT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661251 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, WHEN PASSING THE TWINFIX IMPLANT IT PRESENTED RESISTANCE AND WAS IMPACTED IN ORDER TO ENTER IT, BUT THE SUTURES BROKE. ALL THE BROKEN PIECES WERE RETRIEVED FORM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040476 ↗
• InjuryJan 6, 2023Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A OSTEOSYNTHESIS PERONEUS DISTAL + LIGAMENTOGRAPHY , OSTEOSYNTHESIS WAS PERFORMED WITHOUT COMPLICATIONS AND THE TWINFIX ANCHOR WAS POSITIONED, THE SPECIALIST IMPACTED THE TIP OF THE ANCHOR AND INTRODUCED IT TURNING IT AROUND, AT THE MOMENT OF THE PASSAGE THE DISTAL PART OF THE HANDLE OF THE ANCHOR WAS BENT IN GREAT PART AVOIDING THAT THE ANCHOR ENTERED COMPLETELY. THE SPECIALIST TRIED TO WITHDRAW THE ANCHOR AND IT WAS NOT POSSIBLE TO BE WITHDRAWN, IT WAS NECESSARY TO PASS A CUTTER TO BE ABLE TO CUT THE HALF OF THE ANCHOR THAT WAS LEFT ON THE OUTSIDE. A SECOND ANCHOR WAS PASSED AND THE SAME THING HAPPENED, THE HANDLE OF THE ANCHOR TWISTED IN ITS DISTAL PART, THE SPECIALIST DECIDED TO REMOVE THE HANDLE AND IMPACTED THE IMPLANT, HOWEVER THE ANCHOR REMAINED A LITTLE OUTSIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 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 16112667 ↗
• InjuryOct 24, 2022Break; Break

  IT WAS INFORMED THAT DURING AN HUMERUS OSTEOSYNTHESIS PROCEDURE, AT THE END OF THE PROCEDURE, THE SPECIALIST INFORMED THE TWINFIX ANCHOR BROKE WHEN IT WAS PLACED IN THE CORRESPONDING PLACE. THE ANCHOR WAS CHECKED AND IT WAS IN PERFECT CONDITION, IT WAS NOT BROKEN OR FRACTURED. THEN, THE SPECIALIST INFORMED THAT THE SCREW WAS IN GOOD CONDITION, BUT HE INDICATED THAT THE SUTURES CAME LOOSE FROM THE SCREW WHEN THEY WERE IN THE ANCHOR, IT WAS CHECKED AND INDEED THE SUTURES WERE DISASSEMBLED. THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658733 ↗
• InjurySep 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE TWINFIX SUTURE ANCHOR PULLED OUT. THE PROCEDURE WAS COMPLETED WITH A 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 15397632 ↗
• InjuryAug 16, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING AN ANKLE PROCEDURE, THE SITE OF INSERTION OF THE TWINFIX IMPLANT WAS DETERMINED AND THE INITIATION WAS PERFORMED WITH THE DRILL 2.8 X 15 MM, IT WAS INTRODUCED IN THE BONE AND IT WAS NOT POSSIBLE TO REACH THE FIRST LASER LINE, THE SCREWDRIVER SUFFERED TORSION AND IT WAS NOT POSSIBLE TO RETURN THE IMPLANT DURING THIS MANEUVER THE SUTURE THREADS BROKE, IT WAS TRIED WITH OTHER INSTRUMENTS AND IT WAS NOT POSSIBLE TO REMOVE THE IMPLANT WHICH REMAINED 5 MM OUTSIDE THE BONE. ANOTHER ATTEMPT WAS MADE TO INSERT THE IMPLANT IN ANOTHER NEW SITE WITH A 3.2 DRILL BIT BUT BEFORE REACHING THE FIRST LASER LINE THE SCREWDRIVER SUFFERS TORSION AGAIN IT WAS IMPOSSIBLE TO INSERT OR REMOVE THE IMPLANT AND AGAIN IT REMAINED OUTSIDE THE BONE, THE TISSUE WAS TRIED TO COVER THE IMPLANT BUT IT PROTRUDES. THE PROCEDURE WAS COMPLETED WITH A ONE-HOUR SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15234765 ↗
• InjuryAug 16, 2022Difficult to Insert; Material Deformation; Material Split, Cut or Torn; Difficult to Insert; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANKLE PROCEDURE, THE SITE OF INSERTION OF THE TWINFIX IMPLANT WAS DETERMINED AND THE INITIATION WAS PERFORMED WITH THE DRILL 2.8 X 15 MM, IT WAS INTRODUCED IN THE BONE AND IT WAS NOT POSSIBLE TO REACH THE FIRST LASER LINE, THE SCREWDRIVER SUFFERED TORSION AND IT WAS NOT POSSIBLE TO RETURN THE IMPLANT DURING THIS MANEUVER THE SUTURE THREADS BROKE, IT WAS TRIED WITH OTHER INSTRUMENTS AND IT WAS NOT POSSIBLE TO REMOVE THE IMPLANT WHICH REMAINED 5 MM OUTSIDE THE BONE. ANOTHER ATTEMPT WAS MADE TO INSERT THE IMPLANT IN ANOTHER NEW SITE WITH A 3.2 DRILL BIT BUT BEFORE REACHING THE FIRST LASER LINE THE SCREWDRIVER SUFFERS TORSION AGAIN IT WAS IMPOSSIBLE TO INSERT OR REMOVE THE IMPLANT AND AGAIN IT REMAINED OUTSIDE THE BONE, THE TISSUE WAS TRIED TO COVER THE IMPLANT BUT IT PROTRUDES. THE PROCEDURE WAS COMPLETED WITH A ONE-HOUR SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15234657 ↗
• InjuryJul 24, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TENDON TRANSFER PROCEDURE USING THE TWINFIX SUTURE ANCHOR, WHILE MAKING THE SECOND KNOT, THE SUTURE BROKE SO THE KNOT WAS MADE WITH THE OTHER SUTURE THREAD REMAINING STABLE IN THE FIXATION. THEN, WHEN CLOSING THE PATIENT, A STRANGE NOISE WAS HEARD SO THE STITCHES WERE REMOVED AND IT WAS EVIDENCED THAT THE IMPLANT SUTURE WAS BROKEN. THE IMPLANT WAS REMOVED WITH THE ORIGINAL HANDLE AND PROCEEDED TO FINISH THE PROCEDURE USING A NEW IMPLANT. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30MIN. PATIENT'S HEALTH CONDITION IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090721 ↗
• InjuryOct 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANKLE LIGAMENT REPAIR, THE SURGEON PREPPED THE BONE HOLE WITH K-WIRE AND THEN INSERTED THE TWINFIX. HE OPENED THE ANCHOR INSERTER HANDLE WITH A MCDONALD INSTRUMENT TO RELEASE SUTURES WITH NEEDLES. AS HE WAS TAKING RUBBER OFF THE NEEDLES, ONE NEEDLE CAME OFF IN HIS HAND. SUTURES ALL FINE AND OTHER NEEDLES ALL STILL ATTACHED. IT DID NOT AFFECT SURGERY OR THE OUTCOME. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE, USING A MAYO NEEDLE. IT WAS NECESSARY BECAUSE THE NEEDLE CAME OFF THE SUTURE, THE DOCTOR HAD TO USE A MAYO NEEDLE THAT HOSPITAL PROVIDES SO THAT HE CAN THEN STILL USE THE SUTURE AND PASS IT THROUGH THE TISSUE. NO SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627896 ↗
• MalfunctionAug 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ANKLE LIGAMENT RECONSTRUCTION SURGERY, WHEN THE SURGEON INSERTED THE TWINFIX T ANCHORS AND PROCEEDED TO OPEN THE HANDLE TO RELEASE THE SUTURES WITH NEEDLES, THREE OF THE SUTURES HAD NEEDLES ATTACHED EXCEPT ONE NEEDLE THAT DID NOT HAVE A NEEDLE ATTACHED. THE LOOSE NEEDLE FELL OUT AS THE SURGEON OPENED THE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A MAYO NEEDLE FOR THE SUTURE THAT LOST ITS NEEDLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351153 ↗
• InjuryJul 28, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT IN A TENDON ACHILLES REPAIR, THEY STARTED WITH 2.5 DRILL BIT TO CREATE A PILOT HOLE IN ORDER TO SCREW IN ANCHOR SUTURE TO THE TARGET LESION. WHEN ANCHOR PLACEMENT INSERT RELEASE THE NEEDLE FROM THE HANDLE ULTRABRAID SUTURE WAS LACERATED. AND IT WAS UNABLE TO STITCH THE TISSUES. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. A DELAY GREATER THAN 30MIN WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242003 ↗
• InjuryMay 27, 2021Break; Break

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INTERNAL TO PATIENT IN AN ARTHROSCOPY, THE ANCHOR OF THE TWINFIX WAS PLACED AND DEPLOYED CORRECTLY. SURGEON STARTED USING SUTURES AND ONE OF THE NEEDLES THAT SURGEON WAS USING CAME CLEAN OFF OF THE SUTURE IT WAS ATTACHED TO. SURGERY CONTINUED. HE USED OTHER SUTURES THAT STILL HAD NEEDLES ATTACHED CORRECTLY. THE PROCEDURE WAS COMPLETED WITH THE S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898906 ↗
• MalfunctionMay 7, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN A QUADRICEPS SUTURE, THE FIRST ANCHOR BROKE WHILE IMPACTING AND THE WIRE OF THE OTHER TWO ANCHORS HAD COME OUT. THE BROKEN ANCHOR WAS COMPLETELY REMOVED USING PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A COMPETITOR BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. REFERENCE RELATED COMPLAINTS (B)(4) (MDR 1219602-2021-01064 AND 1219602-2021-01065).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794661 ↗
• InjuryNov 26, 2020Break; Insufficient Device Problem Information; Material Split, Cut or Torn; Break; Insufficient Device Problem Information; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A FOOT PROCEDURE, THE NEEDLES CAME OFF FROM THE TWINFIX ANCHOR WHILE TYING THE KNOTS AND OR PASSING. ALSO SOME SUTURE BREAKAGE WAS EXPERIENCED. MAYO NEEDLES HAD TO BE USED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO SIGNIFICANT DELAY WAS REPORTED. NO 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911449 ↗
• InjuryNov 26, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A FOOT PROCEDURE, THE NEEDLES CAME OFF FROM THE TWINFIX ANCHOR WHILE TYING THE KNOTS AND OR PASSING. ALSO SOME SUTURE BREAKAGE WAS EXPERIENCED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO SIGNIFICANT DELAY WAS REPORTED. NO 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 10911442 ↗
• InjuryNov 26, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A FOOT PROCEDURE, THE NEEDLES CAME OFF FROM THE TWINFIX ANCHOR WHILE TYING THE KNOTS AND OR PASSING. ALSO SOME SUTURE BREAKAGE WAS EXPERIENCED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO SIGNIFICANT DELAY WAS REPORTED. NO 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 10911435 ↗
• InjuryNov 26, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A FOOT PROCEDURE, THE NEEDLES CAME OFF FROM THE TWINFIX ANCHOR WHILE TYING THE KNOTS AND OR PASSING. ALSO SOME SUTURE BREAKAGE WAS EXPERIENCED. THE PROBLEM WAS SOLVED CHANGING TO A COMPETITOR DEVICE DUE TO THE NEEDLE CONSISTENTLY FALLING OFF. NO SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911429 ↗
• InjuryNov 13, 2020Break; Break

  IT WAS REPORTED THAT DURING A ANS/ SMALL JOINTS REPAIR PROCEDURE, THE TECHNIQUE WAS BEING CARRIED OUT STEP BY STEP, AT THE TIME THE SUTURING STARTED AT THE SECOND POINT THE TWINFIX TITANIUM THREADS GOT DISENGAGED FROM THE NEEDLE, THIS HAPPENED WITH THE WHITE AND BLUE SUTURES AT THE 4 ENDS. THE SUTURING COULD NOT BE PERFORMED. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW TWINFIX BACK UP DEVICE WAS USED INTO AN ADDITIONAL BONE HOLE TO COMPLETE THE SURGERY. ANCHORS WERE LEFT IN THE PATIENT.

  Patient problems: No Information

  MAUDE report 10835542 ↗
• InjuryAug 20, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A TENDON REPAIR AFTER EXCISION ACCESSORY NAVICULAR, 2 OF THE 4 NEEDLES CAME OFF THE SUTURES. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS 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 10434895 ↗

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.