RIBFIX BLU SYSTEM 76-0017Recalls & reported problems
Biomet Microfixation, Inc · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036202255), received between Mar 18, 2019 and Jul 8, 2019 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Physical Resistance/Sticking4
- Defective Device1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
- No Known Impact Or Consequence To Patient1
- Tissue Damage1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2019Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking
IT WAS REPORTED BY THE SALES ASSOCIATE THAT A TEMPORARY FIXATION SCREW BECAME STUCK IN ONE DRIVER AND ANOTHER DRIVER WAS HARD TO TURN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Information
MAUDE report 8770063 ↗InjuryMay 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION
Patient problems: Tissue Damage
MAUDE report 8634373 ↗MalfunctionApr 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8481220 ↗MalfunctionMar 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED A TEMPORARY PIN BECAME IRREVERSIBLY LODGED IN THE CONTRA ANGLE DRIVER. THE SURGEON WAS PLATING LEFT SIDED RIB WITH RIBFIX BLU. THE PIN WAS ABLE TO BE REMOVED FROM THE PATIENT'S BONE WITHOUT DAMAGING THE BONE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429034 ↗
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- PRECICE® Plating System LP4.5-DRF32Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.