NA 413.340Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982212030), received between Sep 7, 2017 and Oct 25, 2019 — classified as 1 injury, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K000682, K023941); 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. How this data works · Data updated Oct 13, 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.

• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION PROCEDURE OF A TOMOFIX OPENING WEDGE NAIL TIBIAL OSTEOTOMY DUE TO NON-UNION. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH A TOMOFIX OSTEOTOMY SYSTEM ON (B)(6) 2019. THE TOMOFIX PLATE, FIVE (5) LOCKING HEAD SCREWS AND ONE (1) CORTEX SCREW WERE EXPLANTED AND A NEW PLATE AND SCREWS WERE PUT IN WITH THE SAME PLATE AND SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DURING REVISION. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS 4 OF 7 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9241199 ↗
• MalfunctionSep 7, 2017Break; Break

  IT WAS REPORTED THAT DURING A VARUS DEROTATION OSTEOTOMY, AN IMPLANT BROKE DURING INSERTION. THE SURGEON WAS INSERTING A SCREW THROUGH A PLATE TO ADJUST THE HEIGHT OF THE PLATE. AS THE SURGEON WAS REMOVING THE SCREW, THE HEAD OF THE SCREW BROKE OFF THE SHAFT. A BROKEN SCREW REMOVAL SET WAS USED TO ATTEMPT TO REMOVE THE SHAFT. THE SURGERY WAS DELAYED BY ABOUT 20-25 MINUTES TO REMOVE THE SHAFT. UNFORTUNATELY, THE ATTEMPT WAS UNSUCCESSFUL AND THE SURGEON LEFT THE SHAFT IN THE PATIENT AND PROCEEDED TO COMPLETE THE REST OF THE SURGERY. NO OTHER COMPLICATIONS OCCURRED. THE PATIENT¿S STATUS WAS STABLE AND RECOVERING FINE. NO ADDITIONAL INFORMATION AVAILABLE. CONCOMITANT MEDICAL DEVICES: UNKNOWN PLATE (PART UNKNOWN, LOT UNKNOWN 1 QUANTITY).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6850230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000682, K023941. 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