TWINFIX 72202633Recalls & reported problems
Smith & Nephew, Inc. · TWINFIX 4.5 AWL DILATOR FOR USE WITH 4.5 MM ANCHOR HOLE PREPARATION · Class 1
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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010647634), received between Jan 11, 2019 and Mar 23, 2023 — classified as 1 injury, 1 malfunction.
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.
Most reported problems
Device problems
- Break2
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
InjuryMar 23, 2023Break; Break
IT WAS REPORTED THAT DURING AN ANKLE OSTEOSYNTHESIS PROCEDURE USING A TWINFIX ULTRA 4.5MM AWL-DILATOR, WHEN IMPACTING THE PRIMER AND SUBSEQUENTLY THREADING IT AS REQUESTED BY THE TECHNICIAN, UPON REMOVAL, IT WAS FOUND THAT THE TIP BROKE INSIDE THE BONE. THE DOCTOR CHOSE NOT TO TRY TO REMOVE IT AND THE PIECE WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 16605045 ↗MalfunctionJan 11, 2019Break
IT WAS REPORTED THAT DURING THE SURGERY THE TIP BROKE IN THE PATIENT'S BONE, IT WAS NOT POSSIBLE TO REMOVE THE TIP. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8242714 ↗
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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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