SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-56-340Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07540194003942), received between Aug 3, 2022 and Aug 3, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K143355); 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 3, 2022Component Incompatible; Product Quality Problem; Inaccurate Information; Component Incompatible; Product Quality Problem; Inaccurate Information

  DURING A SURGERY USING A Ø5.6MMX340MM SLIM NAIL, THE CORRESPONDING PEG SIZE DID NOT FIT INTO THE DISTAL AND PROXIMAL HOLES FOR FIXATION. THE SURGEON DECIDED TO USE ANOTHER DEVICE FOR INTERLOCKING IN THIS PATIENT. THE SLIM NAIL USED WAS FROM A PREVIOUS VERSION OF THE NAIL WITH SMALLER INTERLOCKING HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160573 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143355. One submission often covers many models, so check the product and lot details in each record.

• Z-2278-2019 · May 29, 2019 · Terminated
  SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System