TOMOFIX 440.834Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982220691), received between Jul 9, 2018 and Mar 8, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K023941, K141796); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT THE REMOVAL OF ONE (1) TITANIUM CANNULATED TIBIAL NAIL, TWO (2) UNKNOWN DUAL-CORE SCREWS, TWELVE (12) UNKNOWN LOCKING SCREWS, ONE (1) TI END CAP AND ONE (1) TOMOFIX P TIBIAL HEAD PLATE DUE INFECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) TI TOMOFIX(TM) MEDIAL HIGH TIBIA PLATE-4 HOLES. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11434924 ↗
• InjuryJul 9, 2018Mechanical Problem; Mechanical Problem

  (B)(6) REPORTS THAT DURING REMOVAL OF TOMOFIX LATERAL DISTAL FEMUR PLATE ON AN UNKNOWN DATE, THE SURGEON DESCRIBED THE SCREW AND PLATE JUNCTION STATUS AS ¿COLD WELDING¿. THE SURGEON HAD TROUBLE REMOVING THE TITANIUM TOMOFIX PLATE BECAUSE THE UNKNOWN SCREWS STRONGLY ADHERED TO THE PLATE. THE SURGEON ALWAYS FINISHED THE LAST SCREW INSERTION THREADS USING A TORQUE LIMITING SCREWDRIVER AS DESCRIBE AND PROPOSED IN THE TECHNIQUE GUIDE. DURING THE REMOVAL, THE SURGEON HAD TO USE A BROKEN SCREW REMOVAL SET AND DIAMOND BURR TO SHEAR OFF THE SCREW HEAD AT THE PLATE JUNCTION TO ENABLE REMOVAL OF THE PLATE AND SCREW CONSTRUCT. THE SURGEON ADDED THAT THE PLATE ALWAYS ACHIEVED CLINICAL RESULT GOAL BUT THE CONSTRUCT IS A NIGHTMARE TO REMOVE AFTER BONE HEALING. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY RELATED TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A TI TOMOFIX(TM) MEDIAL HIGH TIBIA PLATE-4 HOLES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7669697 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023941, K141796. One submission often covers many models, so check the product and lot details in each record.

• Z-0473-2014 · Oct 9, 2013 · Terminated
  Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and