NA 201.363.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982141880), received between Sep 28, 2023 and Sep 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K063049); 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.

• MalfunctionSep 28, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT (ON B)(6) 2023 THE SURGEON HAD ISSUES WITH SCREWS GETTING PURCHASE IN THE BONE. IT'S POSSIBLE THAT THERE WAS A FRAGMENT THERE, HOWEVER IT WAS UNKNOWN. HE DECIDED TO LEAVE THE THIRD SCREW OUT BECAUSE HE FELT COMFORTABLE WITH THE FIXATION WITH TWO SCREWS. ADDITIONALLY WHEN THE FIRST 1.1 DRILL BIT WAS SELECTED BEFORE USE, IT WAS DETERMINED TO BE BENT. IT WAS REMOVED, AND ANOTHER DRILL BIT WAS USED SUCCESSFULLY. THE SURGERY WAS DELAYED FOR 5 MINUTES BUT IT WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WAS THERE. THIS REPORT IS FOR ONE (1) 2.0 CORTEX SCREW SLF-TPNG SD RECESS 13. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836734 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. 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