NA 202.870Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982145048), received between Aug 20, 2021 and Jun 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K010321, K050110, K063049, K102694, K112583, K113364); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ORDER ARRIVED WITH TWO MISSING SCREWS. THE SCREWS WERE NEVER RECEIVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574263 ↗
• MalfunctionJun 20, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON MAY 24, 2024, THE ORDER ARRIVED WITH TWO MISSING SCREWS. THE SCREWS WERE NEVER RECEIVED. THERE WAS NO PATIENT INVOLVEMENT, THIS REPORT INVOLVES ONE (1) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574244 ↗
• 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) 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM. THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12349122 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010321, K050110, K063049, K102694, K112583, K113364. 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-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon
• 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
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor