NA 04.211.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982118950), received between Sep 27, 2022 and Apr 10, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K100776, K103243); 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.

• MalfunctionApr 10, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF. THE METAL ON THE HEAD OF THE SCREW WAS SLIGHTLY PEELED OFF, CAUSING THE SCREW TO STRIP DURING INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839603 ↗
• InjuryJan 9, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR CLAVICULAR DIAPHYSIS WITH THE PRODUCTS IN QUESTION. TWO MONTHS LATER ON (B)(6) 2022, IT BACKED OUT. THE DOCTOR HAS CONFIRMED BY X-RAY THAT THERE ARE NO BROKEN PIECES OR OTHER RESIDUALS IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 10MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16121077 ↗
• MalfunctionOct 19, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION OF THE CLAVICLE ON (B)(6) 2022. WHILE THE SURGEON WAS FIXING THE MEDIAL FRAGMENT WITH THE CS1 PLATE, THE SURGEON DRILLED, MEASURED, AND MANUALLY INSERTED THE APPROPRIATE LOCKING SCREWS WITH VA SLEEVE. HOWEVER, THE SCREW HAD A PIECE OF METAL ON IT AND WAS NOT TORQUED. SIMILARLY, WHEN THE SURGEON DRILLED, MEASURED, AND INSERTED THE RELEVANT PRODUCT WITH A VA SLEEVE INTO ANOTHER HOLE, IT WAS TORQUED AND USED WITHOUT PROBLEMS. THE SURGEON COMMENTED THAT IT HAPPENED BECAUSE THE SCREW WENT IN AT A STRONGER OBLIQUE ANGLE THAN THE DIRECTION IN WHICH IT WAS DRILLED. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THERE WAS NO PROBLEM WITH BONE FIXATION. THERE WAS NO SURGICAL DELAY IN RELATION TO THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCKNG SCR 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 15632010 ↗
• InjurySep 27, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR A FRACTURE OF ELBOW BONE HEAD WITH THE PLATE AND SCREWS IN QUESTION. ON AN UNKNOWN DATE, THE FIXATION WAS LOST. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED AND COMPLETED SUCCESSFULLY WITH A NEW PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 10MM. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15490705 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100776, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• 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