NA 04.211.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982119100), received between Aug 4, 2021 and Apr 10, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A TRANSCONDYLAR FRACTURE OF THE DISTAL HUMERUS. AFTER IMPLANTING A POSTERIOR LATERAL PLATE, THE SURGEON BEGAN IMPLANTING THE MEDIAL PLATE, BUT THREE SCREWS IDLED AND NO TORQUE COULD BE APPLIED. THE FIRST SCREW WAS INSERTED AFTER DRILLING USING A 2.7 VA DRILL GUIDE, BUT THE SCREW IDLED WHEN THE HEAD CAME NEAR TO THE PLATE. THIS SCREW WAS REMOVED BECAUSE A METAL FRAGMENT WAS GENERATED. THE SECOND SCREW WAS INSERTED INTO THE SAME HOLE AS THE FIRST, BUT IT ALSO IDLED. TORQUE COULD BE LIGHTLY APPLIED TO THIS SCREW SO IT WAS LEFT IN THE HOLE. THE THIRD SCREW WAS INSERTED INTO ANOTHER HOLE AFTER DRILLING WITH THE VA DRILL GUIDE, BUT NO TORQUE COULD BE APPLIED. THIS SCREW WAS ALSO LEFT IN THE HOLE. ANOTHER DRILL GUIDE WAS USED AND THE ISSUES WITH SCREW IDLING AND LACK OF TORQUE WERE RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT, IT WAS CONFIRMED VIA X-RAY THAT NO FRAGMENTS REMAINED WITHIN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080485 ↗
• 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 36MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860339 ↗
• InjurySep 16, 2022Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER THE INITIAL SURGERY, TWO SCREWS CAME OUT ON AN UNKNOWN DATE, SO A REVISION SURGERY WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 36MM. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15438174 ↗
• InjuryAug 4, 2021Migration; Migration

  IT WAS REPORTED THAT PARTS WERE IMPLANTED IN 2017. LAST YEAR THE SCREWS STARTED BACKING OUT, AND THE PLATE AND SCREWS WERE REMOVED IN (B)(6) OF 2020. A NEW PLATE. WAS NOT IMPLANTED AT THAT TIME DUE TO HOSPITAL RESTRICTIONS ON SURGERIES DUE TO COVID. A NEW PLATE WAS IMPLANTED IN (B)(6) 2021. PATIENT STATUS IS UNKNOWN. NO SURGICAL DELAY. THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) 2.7 TI VAL SCR SLF-TPNG T8 SD REC 36 THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12277534 ↗