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NA 458.830Recalls & reported problems

Synthes (U.S.A.) LP · 4.0MM TI LOCKING SCREW 30MM- FOR IM NAILS · Class 2

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 10886982230195), received between Aug 7, 2018 and Aug 7, 2018 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K000089, K040762); 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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO REVISION ON (B)(6) 2018, TO REMOVE THE FOLLOWING HARDWARE: ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE 6 HOLES, ONE (1) TITANIUM LOCKING SCREW 60MM, ONE (1) TITANIUM LOCKING SCREW 76MM, ONE (1) TITANIUM LOCKING SCREW 30MM, ONE (1) TITANIUM LOCKING SCREW 50MM AND ONE (1) CORTEX SCREW SELF-TAPPING, DUE TO OSTEOMYELITIS. THE HARDWARE WAS ORIGINALLY IMPLANTED FOR A FRACTURE REPAIR SURGERY TO THE RIGHT TIBIA ON AN UNKNOWN DATE IN 2017. THIS IS REPORT 5 OF 7 FOR (B)(4).

    Patient problems: Unspecified Infection

    MAUDE report 7758227 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000089, K040762. One submission often covers many models, so check the product and lot details in each record.

  • Z-2051-2015 · Jun 3, 2015 · Terminated
    TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
  • Z-2058-2013 · Nov 2, 2012 · Terminated
    Synthes Trauma Nail System. The devices are indication for bone fixation.

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.