LIGAFIX LIGAFIX 30 round headRecalls & reported problems
S.B.M · Absorbable interference screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760154004381), received between Jan 14, 2025 and Jan 14, 2025 — classified as 1 malfunction.
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
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
(B)(4). INCIDENT OCCURED IN PERU. EVENT DESCRIPTION COMMUNICATED. "EL PRESENTE CORREO PARA INFORMARLES SOBRE LO ACONTECIDO EN UNA CIRUGÍA EL DÍA DE AYER (B)(6) 2024. EL TORNILLO AL SER COLOCADO POR EL FÉMUR SE QUEBRÓ, LO QUE OCASIONÓ QUE EL TORNILLO SE CORRA POR VÁSTAGO DEL DESTORNILLADOR Y NO SE LOGRÓ COLOCAR EN LA CORTICAL DEL FÉMUR. SE RETIRÓ Y SE COLOCÓ OTRO TORNILLO LIGAFIX". THIS EMAIL IS TO INFORM YOU ABOUT WHAT HAPPENED IN A SURGERY YESTERDAY (B)(6) 2024. THE SCREW WHEN BEING PLACED THROUGH THE FEMUR BROKE, WHICH CAUSED THE SCREW TO RUN DOWN THE SCREWDRIVER SHAFT AND FAILED TO BE PLACED IN THE CORTEX OF THE FEMUR. IT WAS REMOVED AND ANOTHER LIGAFIX® SCREW WAS PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21148977 ↗
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.
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