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NA 04.043.440SRecalls & reported problems

Synthes GmbH · TIBIAL NAIL-ADVANCED / 12MM 360MM / STERILE · Class 2 · Implant

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 10886982298096), received between Feb 18, 2022 and Feb 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201336); 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

Device problems

  • Device-Device Incompatibility1

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.

  • MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WITH A TIBIA SHAFT FRACTURE WAS BEING TREATED WITH A SUPRAPATELLAR TIBIAL NAIL. DURING INSERTION OF THE TIBIAL NAIL, THE PROTECTION SLEEVE INNER METAL PORTION BECAME DELAMINATED FROM THE PLASTIC PORTION OF THE SLEEVE. THIS WAS IDENTIFIED PRIOR TO LOCKING SCREW INSERTION. THE NAIL WAS EXPLANTED, THE PIECES OF THE SLEEVE WERE REMOVED, AND THE NAIL WAS REINSERTED. THERE WERE FIFTEEN MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A TIBIAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13561128 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. One submission often covers many models, so check the product and lot details in each record.

  • Z-0228-2026 · Sep 26, 2025 · Open, Classified
    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva
  • Z-0229-2026 · Sep 26, 2025 · Open, Classified
    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva

Other NAIL, FIXATION, BONE devices

All NAIL, FIXATION, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.