TWINFIXRecalls & reported problems across all models
Smith & Nephew, Inc. · 48 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,450
- Deaths reported
- 0
- Injuries reported
- 559
- Recalls
- 0
We found 48 models of TWINFIX by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 1,450 adverse event reports in the FDA's MAUDE database, received between May 2, 2017 and Jun 29, 2026 — classified as 559 injuries, 891 malfunctions.
The most frequently reported specific device problem is “Break” (905 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 TWINFIX problems
Device problems
- Break905
- Material Separation147
- Fracture94
- Material Deformation72
- Device Dislodged or Dislocated67
- Corroded43
- Adverse Event Without Identified Device or Use Problem38
- Detachment of Device or Device Component36
Patient problems
- No Clinical Signs, Symptoms or Conditions893
- No Known Impact Or Consequence To Patient290
- Foreign Body In Patient80
- No Information61
- Perforation50
- Device Embedded In Tissue or Plaque27
- Rupture27
- No Consequences Or Impact To Patient16
TWINFIX models
48 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TWINFIX 72202595FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE446 reports
- TWINFIX 72202597FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- TWINFIX 72200755FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE117 reports
- TWINFIX 72202599FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE76 reports
- TWINFIX 72200750FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE54 reports
- TWINFIX 72202602FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE54 reports
- TWINFIX 72200752STAPLE, FIXATION, BONE45 reports
- TWINFIX 72202897FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE38 reports
- TWINFIX 72202895FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE35 reports
- TWINFIX 72202618FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE31 reports
- TWINFIX 7210707FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE30 reports
- TWINFIX 72202893FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE26 reports
- TWINFIX 7210708FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE22 reports
- TWINFIX 72202625FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE21 reports
- TWINFIX 72202615FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE21 reports
- TWINFIX 72202600FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE19 reports
- TWINFIX 72202067FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE18 reports
- TWINFIX 72202626FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE16 reports
- TWINFIX 72202624FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE14 reports
- TWINFIX 72202900FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE11 reports
- TWINFIX 72202603FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE7 reports
- TWINFIX 72203784FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE6 reports
- TWINFIX 72202896FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE6 reports
- TWINFIX 7210116ACCESSORIES,ARTHROSCOPIC5 reports
- TWINFIX 7210301FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE4 reports
- TWINFIX 72202894FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE4 reports
- TWINFIX 72202616FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE3 reports
- TWINFIX 7210302FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- TWINFIX 7210710FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE3 reports
- TWINFIX 72202622FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- TWINFIX 7210709FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- TWINFIX 72202610FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE2 reports
- TWINFIX 72202633ACCESSORIES,ARTHROSCOPIC2 reports
- TWINFIX 72202634ACCESSORIES,ARTHROSCOPIC2 reports
- TWINFIX 72203103FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE2 reports
- TWINFIX 72202611FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- TWINFIX 7209500ACCESSORIES,ARTHROSCOPIC1 report
- TWINFIX 7210300STAPLE, FIXATION, BONE1 report
- TWINFIX 7210292FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- TWINFIX 72200777FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- TWINFIX 72200758STAPLE, FIXATION, BONE1 report
- TWINFIX 72200762STAPLE, FIXATION, BONE1 report
- TWINFIX 72200796FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- TWINFIX 72202623FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- TWINFIX 72202631FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- TWINFIX 72202898FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- TWINFIX 72203104FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- TWINFIX 72202619FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
Recent TWINFIX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE TWINFIX ULTRA BROKE WHILE IN USE. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHO. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25661982 ↗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 ↗MalfunctionJun 29, 2026Material Integrity Problem
IT WAS REPORTED THAT, DURING AN INSTABILITY PROCEDURE, WHILE TYING THE SUTURE OF ONE (1) TWINFIX ANCHOR, THE SUTURE MATERIAL GOT DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25658867 ↗MalfunctionJun 29, 2026Break
IT WAS REPORTED THAT, DURING ROTATOR CUFF REPAIR SURGERY, ONE (1) TWINFIX ANCHOR WAS BROKEN DURING THE IMPLANTATION. THE PROCEDURE WAS RESUMED WITH AN EQUIVALENT S+N BACK UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS REPORTED. NO SURGICAL REPORT IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648628 ↗MalfunctionJun 16, 2026Break
IT WAS REPORTED THAT DURING A PECTORAL MUSCLE REPAIR, ONE (1) TWINFIX ULTRA 5.5MM BROKE DURING PLACEMENT, AS ONLY THE SMOOTH INITIATOR WAS USED INSTEAD OF THE TRIFINE THREADER. THE BONE WAS VERY HARD, THE YOUNG PATIENT PEEKED AT THE WRENCH, AND THE ANCHOR BROKE AT THE WRENCH FITTING. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE, NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525670 ↗MalfunctionJun 2, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE HEAD OF THE TWINFIX ULTRA ANCHOR BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364160 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN WAS INSIDE THE PATIENT, THE SUTURE AND THE HEAD OF TWO (2) TWINFIX ULTRA ANCHORS BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. 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 25345332 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE HEAD OF THE TWINFIX ULTRA ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN S+N EQUIVALENT BACK UP PRODUCT, HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342088 ↗MalfunctionMay 26, 2026Break
IT WAS REPORTED THAT DURING A SMALL JOINT ARTHROSCOPY, AFTER ONE (1) TWINFIX ANCHOR HAD BEEN PLACED AND THE TISSUES WERE BEING GATHERED FOR SUTURING, THE SUTURE FAILED, BREAKING WITHOUT ANY TRACTION APPLIED OR KNOT TYING PERFORMED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINS, USING A COMPETITOR DEVICE. 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 25280765 ↗MalfunctionMay 21, 2026Break
IT WAS REPORTED THAT DURING A BANKART PROCEDURE, THE TWINFIX TI 2.8 ULTRABRAID'S THREAD GOT BROKEN, IT GOT CUT OFF. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25238007 ↗MalfunctionMay 11, 2026Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, AFTER INSERTING THE TWINFIX ANCHOR, IT BROKE INSIDE THE PATIENT. THE SURGEON FOLLOWED THE CORRECT TECHNIQUE, AND EVEN SO, IT BROKE. THE ANCHOR WAS DAMAGED INSIDE THE PATIENT, BUT IT WAS HELD IN PLACE BY THE ANCHOR WIRES; IT WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145650 ↗MalfunctionMay 5, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A RUPTURE OF THE SUPRASPINATUS TENDON ON THE RIGHT SHOULDER, WHEN PULLING THE SUTURE, THE HEAD TWINFIX ANCHOR CAME OFF AND SEPARATED FROM THE ANCHOR STEM, MAKING IT IMPOSSIBLE TO USE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE, NO VOIDS WERE LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A 4.5 MM TAP AND THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT STATUS WAS FINE.NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089708 ↗MalfunctionMay 3, 2026Fracture
IT WAS REPORTED THAT, DURING A SURGERY, THE HEAD OF THE TWINFIX ANCHOR WAS FRACTURED WHEN SCREWING IN. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062900 ↗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 ↗MalfunctionApr 27, 2026Fracture; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR, THE TWINFIX ULTRA PK ANCHOR SLIPPED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP INSERTED INTO THE ORIGINAL BONE HOLE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001079 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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