TWINFIX 72200755Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 03596010577986), received between May 9, 2017 and Jun 29, 2026 — classified as 55 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Break” (61 reports).

2 other recalls cover devices cleared under the same FDA submission (K152566, 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. 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 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TWINFIX ANCHOR JAMMED, IT WAS NEITHER GOING IN NOR OUT, AND THE CABLE ROTATED FREELY. THE DOCTOR LEFT IT INSIDE THE PATIENT'S BONE AND REMOVED THE WIRES. THE ANCHOR REMAINED INTACT INSIDE THE PATIENT'S SHOULDER. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25659787 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWINFIX TI 5.0 ULTRABRAID BROKE WHILE SCREWING IT INTO THE PRE-DRILLED HOLE. ALL PARTS OF THE BROKEN ANCHOR WERE REMOVED FROM THE JOINT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001886 ↗
• MalfunctionJan 19, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF TEAR SURGERY, WHILE DEPLOYING TWINFIX TI 5.0 ULTRABRAID ANCHOR , IT GOT BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111839 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT, DURING AN OPEN SHOULDER PROCEDURE, AFTER DRILLING THE INITIAL BONE HOLE, THE TWINFIX ANCHOR BROKE WHILE IT WAS BEING MANUALLY SCREWED IN. IT WAS REQUIRED TO DRILL ANOTHER HOLE AND A 3.5 MM DRILL WAS USED TO INSERT THE ANCHOR INTO THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23955951 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHEN THE SURGEON PUT A TWINFIX ANCHOR IN THE PILOT HOLE, IT BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767548 ↗
• MalfunctionNov 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, WHEN THE SURGEON INSERTED ONE (1) ULTRABRAID SUTURE ANCHOR INTO THE PILOT HOLE, THE ANCHOR BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23564222 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF ARTHROSCOPY, WHILE THE TWINFIX'S ANCHOR WAS BEING PLACED ON THE PATIENT, IT BROKE AT THE POINT WHERE IT CONNECTS TO THE CABLE. THE BROKEN DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410892 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SHOULDER AND CUFF PROCEDURE, TO LOCATE THE TWINFIX PLACEMENT POINT, THE PUNCTURER WAS USED AND PLACED ON THE ANCHOR BEFORE CHECKING THE INTRODUCTION MARK. THE ANCHOR MADE THE TORQUE KNOBS AND CAME TO A BREAK, BETWEEN THE THREADS OF THE ANCHOR AND THE THREADS, A NEW PUNCTURE WAS MADE AND ANOTHER ANCHOR WAS PLACED WITH SUCCESS. THE BROKEN ANCHOR WAS NOT REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 22801398 ↗
• MalfunctionJul 21, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SETUP, WHEN THE OUTER PACKAGE OF THE TWINFIX TI 5.0 ULTRABRAID WAS OPENED, IT WAS FOUND THAT THE INNER PACKAGING WAS LEAKING AIR, THE STERILE BARRIER WAS COMPROMISED, THERE WAS A BACKUP DEVICE AVAILABLE, NO SURGICAL DELAY WAS REPORTED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562325 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A ROTATOR CUFF REPAIR PERFORMED IN MARCH 9TH OF 2023, IN WHICH A 5.0 TITANIUM TWINFIX SUTURE ANCHOR WAS IMPLANTED, FROM THE SECOND HALF OF 2023 THE PATIENT HAD RED ITCHY SKIN SORES/PIMPLES WITH AN OPEN HEAD ON IT'S CHEST, WAISTLINE AREA, BACK, BUTTOCKS, ARMS AND LEGS CAUSED BY AN ALLERGIC REACTION. THE ADVERSE EVENT WAS TREATED WITH CLOBETASOL CREAM AND ONE STEROID SHOT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Swelling/ Edema

  MAUDE report 22391537 ↗
• MalfunctionJun 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE TWINFIX TI 5.0 ULTRABRAID SCREW FRACTURE WHEN TRYING TO IMPLANT IT. ALL WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINALLY DRILLED BONE HOLE AND LEAVING NO VOID IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209893 ↗
• MalfunctionMay 14, 2025Material Fragmentation; Failure to Advance; Material Fragmentation; Failure to Advance

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN THE FIRST TWINFIX ANCHOR WAS INSERTED, THE MEAMA PROGRESSED HALFWAY THROUGH THE TUNNEL, CAUSING THE ANCHOR TO BE SPRAYED WITH THE WRENCH. THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023597 ↗
• MalfunctionFeb 18, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN OPEN ELBOW PROCEDURE, ONE (1) UNIT OF THE TWINFIX ANCHOR BECAME STUCK WHILE BEING INSERTED INTO THE BONE, PREVENTING FORWARD OR BACKWARD MOVEMENT. IT WAS REMOVED FROM THE PATIENT USING A CHISEL, TWEEZERS, AND HAMMER. THE SURGERY WAS COMPLETED WITH A BACKUP DEVICE, RESULTING IN A SIGNIFICANT SURGICAL DELAY OF 40 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399823 ↗
• MalfunctionNov 30, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ATHROSCOPY, THE TWINFIX TI 5.0 ULTRABRAID ANCHOR WAS DISPLACED, THE CABLE BECAME TWISTED AND IN AN ATTEMPT TO UNTWIST THE CABLE, THE ANCHOR EXPANDED WHEN INSERTING THE ANCHOR. THE PIECE WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20813855 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TWINFIX ANCHOR BROKE WHILE BEING IMPLANTED. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A 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 20784313 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, WHEN TYING KNOTS AT THE ENDS OF THE TENDON, THE TWINFIX ANCHOR WIRES WORE OUT AND BROKE WHILE USED WITH A KNOT PUSHER, THE BROKEN WIRES WERE REMOVED FROM INSIDE THE PATIENT WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758620 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED DURING A VIDEO SHOULDER AND CUFF PROCEDURE THAT WHEN INTRODUCING THE INITIAL PORTION OF THE TWINFIX ANCHOR AND PLACING IT, IT BROKE AFTER A FEW TURNS. THE BROKEN PIECE OF THE ANCHOR WAS REMOVED, AND A SECOND ANCHOR WAS PLACED INTO THE SAME HOLE AS THE FIRST. HOWEVER, THE SECOND ANCHOR ALSO BROKE, AND THERE WAS NO WAY TO REMOVE IT FROM THE HEAD OF THE HUMERUS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20729862 ↗
• MalfunctionApr 16, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING A PATELLAR LCA, THE TWINFIX CABLE WAS ROTATING IN FALSE AND THEREFORE THE ANCHOR WAS NOT PROGRESSING. THE ANCHOR AND ANCHOR'S CABLE WERE REMOVED USING A GOUGE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122390 ↗
• InjuryJan 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ANCHOR OF THE TWINFIX WAS SWOLLEN, NO FURTHER DETAILS. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE, HOWEVER, IT WAS MENTIONED THAT AN ADDITIONAL BONE HOLE WAS NEEDED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18511115 ↗
• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE TWINFIX' S ANCHOR BROKE WHILE BEING INSERTED IN THE PILOT HOLE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222574 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREADS OF THE TWINFIX BROKE JUST AFTER THE DEPLOYMENT, IT WAS INSIDE THE PATIENT AND WAS REMOVED ARTHROSCOPICALLY WITH INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN THE SAME HOLE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. SURGEONS WAS HAPPY WITH OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210852 ↗
• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER THE ANCHOR WAS IMPLANTED, WHEN THE SURGEON USED AN ELECTRIC SCALPEL TO OPEN MORE SPACE IN THE CAVITY, ENDED UP CUTTING THE TWINFIX ANCHOR SUTURE INSIDE THE PATIENT; THE ANCHOR AND THE SUTURE WERE COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976991 ↗
• MalfunctionSep 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A COLLATERAL LIGAMENT REPAIR SURGERY, THE TIP OF THE METAL SHAFT OF THE TWINFIX ANCHOR WAS BROKEN; THE BROKEN PIECES WERE REMOVED USING SUCTION. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843964 ↗
• MalfunctionSep 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER IMPLANTING THE TWINFIX ANCHOR A SUTURE THREAD GOT CUT OFF FROM THE IMPLANT WHILE PULLING ON IT AFTER KNOTTING. HOWEVER, SINCE ONE THREAD REMAINED ATTACHED TO THE ANCHOR, IT WAS DECIDED TO REMOVE THE CUT-OFF SUTURE THREAD AND KEEP THE ATTACHED ONE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AND IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17810380 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW SINGLE PULLEY DOUBLE-STRAND ANCHOR SUTURE FIXATION OF THE CORONOID PROCESS IN TERRIBLE TRIAD OF THE ELBOW INJURY, 2 PATIENTS HAD AN EXTENSION LAG OF 25-30 DEGREES AFTER AN ELBOW PROCEDURE USING A TWINFIX ULTRA DEVICE. THE CONDITION DID NOT AFFECT THE LIFE QUALITY OF THE PATIENTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 17808821 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152566, K972326. One submission often covers many models, so check the product and lot details in each record.

• Z-0581-2025 · Oct 29, 2024 · Open, Classified
  BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
• 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.