ACUFEX Meniscal Root Repair 71935070Recalls & reported problems
Smith & Nephew, Inc. · MENISCAL ROOT REPAIR PACK WITH ULTRABRAID · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556533291), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Unstable1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Break; Unstable; Break; Unstable
IT WAS REPORTED THAT DURING AN ACL WITH MENISCAL ROOT REPAIR AND LET PROCEDURE, ONE (1) CANNULATED DRILL WAS NOT GOING IN PROPERLY, AND WHEN CHECKED, IT WAS NOTICED THAT THE SLEEVE WAS STUCK ON THE MENISCAL ROOT JIG. IT WAS REQUIRED TO POKE FOR THE SLEEVE TO COME OUT, AND SINCE THE END OF THE CANNULATED DRILL GUIDE WAS SERRATED, IT WAS NOT NOTICED THAT THE GUIDE THAT CAME OUT WAS BROKEN. THE BROKEN PIECE WAS NOT REMOVED FROM THE PATIENT AND WAS FOUND ON POST OP X-RAYS, IT WOULD HAVE CAUSED MORE HARM TO REMOVE IT. THE PROCEDURE WAS RESUMED, AFTER A ONE-HOUR SURGICAL DELAY, USING AN ARTHREX COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23291382 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page