NA 201.360.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982141859), received between Aug 20, 2021 and Aug 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY FOR REMOVAL OF HARDWARE. DURING THE SURGERY, IT WAS NOTED THAT VARIOUS SMALL SCREWS BROKE OFF ON VA DISTAL HUMERUS PLATES. THESE SCREWS WERE TOO DIFFICULT TO REMOVE AND HAVE BEEN LEFT IN PATIENT BONE. IT IS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A FRAGMENT GENERATED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNK - PLATES: LATERAL VA-LCP PROXIMAL TIBIA PLATE(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 10MM. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12349152 ↗
• MalfunctionAug 20, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY FOR REMOVAL OF HARDWARE. DURING THE SURGERY, IT WAS NOTED THAT VARIOUS SMALL SCREWS BROKE OFF ON VA DISTAL HUMERUS PLATES. THESE SCREWS WERE TOO DIFFICULT TO REMOVE AND HAVE BEEN LEFT IN PATIENT BONE. IT IS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A FRAGMENT GENERATED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNK - PLATES: LATERAL VA-LCP PROXIMAL TIBIA PLATE(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 10MM . THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12349127 ↗

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