TWINFIX 7210709Recalls & reported problems
Smith & Nephew, Inc. · TWINFIX 6.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES ONE ULTRABRAID WHITE SUTURE AND ONE ULTRABRAID COBRAID SUTURE WITH NEEDLES, STERILE · Class 2 · Implant
All models of TWINFIX (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010532213), received between Apr 13, 2018 and Oct 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. 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
- Detachment of Device or Device Component1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THREE (3) TWINFIX ANCHORS FAILED IN THE SAME WAY. THE NEEDLE FELL FROM THE DEVICE WHILE IT WAS IN USE. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICES, WITH ANOTHER SINGLE-PACK NAIL. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20346813 ↗MalfunctionApr 13, 2018Device Operates Differently Than Expected
IT WAS REPORTE THAT WHEN THE ANCHOR WAS DEPLOYED AND TOOK OUT THE NEEDLES THEY LOOSENED FORM THE SUTURE. NEEDLES WITH EYELET WERE USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7430569 ↗
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 · TerminatedTwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- 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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