NA 201.790Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982142887), received between Apr 12, 2018 and Apr 12, 2018 — classified as 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K002271, K050110, K063049, K112583); 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 16, 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.

• MalfunctionApr 12, 2018Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE ON (B)(6) 2018 THE HEAD OF A 2.4MM CORTEX SCREW CAME OFF. THE SCREW WAS PLACED IN THE WRONG POSITION, AND WHEN AN ATTEMPT WAS MADE TO REMOVE IT THE HEAD CAME OFF. THE SURGEON ATTEMPTED TO REMOVE THE SCREW WITH A SCREWDRIVER AND WHEN THAT FAILED ATTEMPTED TO REMOVE IT WITH A PAIR OF PLIERS. THERE WAS NO REPORTED PATIENT CONSEQUENCE, NO SURGICAL DELAY, NO FRAGMENTS AND PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT PARTS: DEVICE: 3.5 CORTEX SCREW (PART NUMBER: 204.840, LOT NUMBER: UNKNOWN, QUANTITY: 1), UNKNOWN SCREWDRIVER (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY: 1), UNKNOWN PLIERS (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426297 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002271, K050110, K063049, K112583. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen