NA 03.120.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982074218), received between Aug 12, 2021 and Aug 11, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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.

• MalfunctionAug 11, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TIP OF THE PUSH-PULL REDUCTION DEVICE IS DAMAGED, IT WILL NOT ENGAGE IN DRILL. A REPLACEMENT INSTRUMENT WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) PULL REDUCTION DEVICE FOR 4.3MM PERCUTANEOUS DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510571 ↗
• MalfunctionMay 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  BREAKING PLATE, SO THEY GOT IT OUT. TREATMENT WAS DONE WITH ANOTHER PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885984 ↗
• MalfunctionApr 20, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PULL REDUCTION DEVICE FOR 4.3MM PERCUTANEOUS DRILL GUIDE WAS DAMAGED. THE INSTRUMENT WAS NOT SHARP ANYMORE AND THE TIP WAS DULL. THIS WAS DISCOVERED INTRAOPERATIVELY, HOWEVER THE DEVICE WAS NOT USED ON THE PATIENT DURING THE PROCEDURE. THERE WERE NO KNOW PATIENT CONSEQUENCES OR PROCEDURAL DELAY. THIS REPORT IS FOR ONE (1) PULL REDUCTION DEVICE F/PERCUTANEOUS DRILL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164166 ↗
• MalfunctionAug 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE DRILL GUIDE WAS NOT CONNECTING/DISCONNECTING EFFICIENTLY. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A PULL REDUCTION DEVICE FOR 4.3MM PERCUTANEOUS DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313443 ↗