NA 201.366.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982141910), received between Nov 5, 2018 and Mar 25, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE PUTTING A 2.0 SCREW CORTEX IN, THE SCREW HEAD STRIPPED OUT. THE SCREW HAD TO BE REMOVED WITH PLIERS, BUT IT WAS SUCCESSFULLY REMOVED. ADDITIONALLY, A SCREW DRIVER SHAFT WAS BENT. THERE WERE 5 MINUTES SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905565 ↗
• 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 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 204.816, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 20MM (PART NUMBER 204.82, LOT UNKNOWN, QUANT

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

  MAUDE report 10442525 ↗
• InjuryNov 5, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIAL NECK/HEAD UTILIZING THE VARIABLE ANGLE (VA) LOCKING Y-PLATE ON (B)(6) 2018. IT WAS FURTHER REPORTED THE FIXATION DID NOT HOLD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE Y-PLATE, FOUR (4) VA LOCKING SCREWS AND FOUR (4) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) 2.0MM CORTEX SCREW. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8037626 ↗
• InjuryNov 5, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIAL NECK/HEAD UTILIZING THE VARIABLE ANGLE (VA) LOCKING Y-PLATE ON (B)(6) 2018. IT WAS FURTHER REPORTED THE FIXATION DID NOT HOLD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE Y-PLATE, FOUR (4) VA LOCKING SCREWS AND FOUR (4) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) 2.0MM CORTEX SCREW. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8037589 ↗

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