NA 04.211.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982119063), received between Sep 11, 2023 and Oct 3, 2023 — classified as 2 malfunctions.

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

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.

• MalfunctionOct 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT A PRIMARY SURGERY FOR AN OLECRANON FRACTURE WITH THE VA 2.7 LOCKING SCREWS. ON (B)(6), 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY BECAUSE BONE FUSION WAS ACHIEVED. TWO VA 2.7 LOCKING SCREWS COULD NOT BE REMOVED DURING THE SURGERY, AND BROKE JUST BELOW THE SCREW HEAD. AFTER THAT, THE SURGEON REMOVED THE PLATE, AND USED A HOLLOW REAMER TO SCRAPE AROUND THE SCREWS THAT REMAINED INSIDE THE BODY, AND WAS ABLE TO REMOVE THEM WITH AN EXTRACTION BOLT. THE SURGEON COMMENTED THAT THERE WAS CONCERN THAT THE SCREW HOLES WERE LARGER BECAUSE THE BONE WAS SCRAPED WITH A HOLLOW REAMER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. THIS REPORT INVOLVES ONE 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 28MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860323 ↗
• MalfunctionSep 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A HUMERAL FRACTURE WITH THE LOCKING SCREW AND PLATE. DURING SCREW INSERTION, THE SCREWS DIDN¿T LOCK TO THE PLATE IN TWO HOLES (SECOND AND SIXTH HOLES FROM THE DISTAL HOLE). THE SURGEON USED A DRILL GUIDE AND DRILL, AND INSERTED THE SCREWS AFTER MEASURING. THAT TIME, TWO SCREWS WERE IDLE, AND THE SURGEON RE-DRILLED AND RE-INSERTED THE SCREWS. THE REINSERTED SCREWS WERE LOCKED TO THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 28MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720242 ↗