NA 03.111.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982072306), received between Feb 1, 2022 and Dec 11, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 reports).

7 other recalls cover devices cleared under the same FDA submission (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE REAMERS IN QUESTION WERE VERY BLUNT. THE SURGEON NOTED THAT THEY HAD TO USE A LOT OF FORCE, AND THE REAMERS WERE NOT CUTTING THROUGH THE BONE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 15MM REAMER W/STOP F/2.4MM VAL INTERCARPAL FUSION PLATE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18305644 ↗
• MalfunctionNov 27, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT BOTH TIMES THERE HAVE BEEN COMPLAINTS THAT THE REAMERS ON THE LOAN SET ARE VERY VERY BLUNT. SURGEON USED QUITE A LOT OF FORCE AND THE REAMERS WERE NOT CUTTING THROUGH THE BONE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE RELATED COMPLAINT (B)(4) CAPTURES THE FIRST INSTANCE REPORTED BY THE REPORTER. THIS REPORT IS FOR ONE (1) 15MM REAMER W/STOP F/2.4MM VAL INTERCARPAL FUSION PLATE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18209884 ↗
• MalfunctionFeb 1, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL BIT WOULD NOT CUT AND WAS BLUNT. THERE WAS A SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) 15MM REAMER W/STOP F/2.4MM VAL INTERCARPAL FUSION PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13414705 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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-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-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