NA 03.113.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982072870), received between Jul 30, 2019 and Jul 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON JUNE 21, 2021, THE GUIDING BLOCK AND THE LOCKING ATTACHMENT PLATE GOT STUCK AND WERE NOT COME OFF DURING ASSEMBLY FOR DEMONSTRATION. ALSO, THE GUIDING BLOCK CAME OFF EVENTUALLY. AS WELL AS THE CONNECTING SCREW ALSO CAME OFF AT THE SAME TIME. THE TIP OF THE SCREWDRIVER WHICH WAS USED TO LOCK THE UPPER PART OF THE CONNECTING SCREW HAD BEEN CHIPPED OFF. THE SCREWDRIVER WAS UNABLE TO GRASP THE UPPER PART OF THE CONNECTING SCREW. THESE DEVICES AND IMPLANTS WERE PREPARED FOR DEMONSTRATION IN STUDY MEETING. THESE EVENTS DONT INCLUDE ANY PATIENTS. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) SCREWDRIVER STARDRIVE T15/ SELF-RETAINING/272MM. THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193514 ↗
• MalfunctionJul 30, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED ON (B)(6) 2019, ONE (1) INSERTION HANDLE FOR LOW BEND MEDIAL TIBIAL PLATE RIGHT WAS MISSING THE CONNECTING SCREW OR THE AIMING ARM. IT WAS ALSO MENTIONED THAT THE RAD TECH TRYING TO REMOVE THE CONNECTING SCREW FROM ONE (1) INSERTION HANDLE FOR LOW BEND MEDIAL TIBIAL PLATE WHICH WAS THE LEFT ONE TRYING TO PUT IT IN THE RIGHT ONE AND UPON THE CONNECTING SCREW WAS CROSS-THREADED WITH THE INSERTION HANDLE. LASTLY, ONE (1) STAR DRIVE SCREWDRIVER WAS DAMAGED WHILE TRYING TO REMOVE THE CONNECTING SCREW. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8843679 ↗