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NA 04.033.042SRecalls & reported problems

Synthes GmbH · 10MM / TI CANN FRN / PF 420MM / RIGHT - STERILE · Class 2 · Implant

Data updated Oct 16, 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 10886982270849), received between Sep 16, 2022 and Sep 16, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Joint Laxity1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A CONCERN OVER THE STABILITY OF FX: REMOVAL OF NAIL AND SCREWS. AN IM REAMING OF FEMORAL CANAL WAS COMPLETED. THE SURGEON PUT IN LARGER NAIL / SUPPLEMENT WITH A PROXIMAL FEMUR HOOK PLATE. THIS REPORT IS FOR ONE (1) 10 / TI CANN FRN / PF 420 / RIGHT - SILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

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

    MAUDE report 15437753 ↗

Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices

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Sources and updates

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