TWINFIX 72202634Recalls & reported problems
Smith & Nephew, Inc. · TWINFIX 5.5/6.5 AWL DILATOR FOR USE WITH 6.5 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010647641), received between Aug 26, 2020 and Nov 24, 2025 — classified as 2 injuries.
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
Patient problems
- Foreign Body In Patient1
- 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.
InjuryNov 24, 2025Break; Break
IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, UPON INSERTING THE MALE COMPONENT OF THE AWL-DILATOR TWINFIX INTO THE PATIENT'S BONE, THE TIP BROKE DUE TO THE BONE BEING TOO HARD, IT COULD NOT BE REMOVED. THE TIP OF THE PRODUCT REMAINED EMBEDDED IN THE PATIENT'S BONE. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23631470 ↗InjuryAug 26, 2020Break; Break
IT WAS REPORTED THAT WHILE PERFORMING A PROXIMAL HAMSTRING REPAIR, PRIOR TO PLACING A HEALICOIL ANCHOR INTO THE ISCHIAL TUBEROSITY, THE SURGEON PREPPED THE HOLE USING A S&N HEALICOIL TAP, WHILE SCREWING IN OR UNSCREWING THE TAP, THE SHAFT BROKE OFF THE THREADED PORTION/ TIP LEAVING THE THREADED PORTION INSIDE THE PATIENTS BONE. THE SURGEON THEN HAD TO REMOVE THE THREADED PORTION/ TIP FROM THE BONE. THE CASE WAS COMPLETED USING QFIX ANCHORS AND NOT WITH THE INTENDED HEALICOIL ANCHORS WITH A DELAY GREATER THAN 30 MINUTES. NO 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 10455032 ↗
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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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