NA 201.374.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982141958), received between Aug 24, 2020 and Aug 24, 2020 — classified as 2 injuries.

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

• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM (PART NUMBER 212.105, LOT UNKNOWN, QUANTITY 1), 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM (PART NUMBER 02.107.304, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/34MM (PART NUMBER 02.118.534, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM (PART NUMBER 02.211.020, LOT UNKNOWN, QUANTITY 2), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM (PART NUMBER 02.211.022, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10443776 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 6MM (PART NUMBER 201.356.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM (PART NUMBER 201.362.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 16MM (PART NUMBER 201.366.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART NUMBER 201.368.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM (PART NUMBER 201.370.97, LOT UNKNOWN, QUANTITY 1), 2.0MM LCP(TM) PLATE 4 HOLES/31MM (PART NUMBER 247.344, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.8

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10442841 ↗

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