TWINFIX 72202894Recalls & reported problems
Smith & Nephew, Inc. · TWINFIX ULTRA 4.5 MM TITANIUM ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE · Class 2 · Implant
All models of TWINFIX (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010652256), received between Mar 5, 2020 and Aug 4, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Device Dislodged or Dislocated1
- Fitting Problem1
- Premature Activation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE TWINFIX TIP BROKE DURING IMPLANTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22700430 ↗InjuryNov 7, 2021Break; Premature Activation; Break; Premature Activation
IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE USING TWINFIX ULTRA SUTURE ANCHOR, BY PLACING THE ANCHOR, IT DEPLOYED FROM THE SHAFT. IT COULD NOT BE USED SINCE THE ANCHOR HAD A BROKEN PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12764167 ↗InjuryOct 20, 2021Fitting Problem; Fitting Problem
IT WAS REPORTED THAT DURING AN ACHILLES TENDON REPAIR WITH A TWINFIX, IN ONE PATIENT THE SIZE WAS DIFFICULT TO DETERMINE, NEEDED TO REDO 2 TIMES. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12665357 ↗MalfunctionMar 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE ANCHOR OF THE TWINFIX ULTRA CAME OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. AN ADDITIONAL BONE HOLE WAS PERFORMED IN ORDER TO PLACE THE BACK-UP DEVICE. NO PATIENT INJURY 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: No Known Impact Or Consequence To Patient
MAUDE report 9795305 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
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- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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