SYMPHONY 2020-00-117Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034530390), received between Sep 29, 2022 and Dec 30, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. DURING THE SURGERY, THE THREADS AT THE TIP OF THE SCREWDRIVER RETENTION SLEEVE WERE DEFORMED BEFORE USE, MAKING IT IMPOSSIBLE TO INSERT THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920534 ↗
• MalfunctionDec 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE DEALING WITH THE INSTRUMENTS THE SALES REP NOTICED THAT THE THREADS ON THE SHORT SYMPHONY POLYAXIAL DRIVE RETENTION SLEEVE WERE BENT. IT WAS UNABLE TO BE ENGAGED WITH A SCREW AFTER SEVERAL ATTEMPTS WITH DIFFERENT SCREWS. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED OR WHETHER IT IMPACTED SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE, SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022644 ↗
• MalfunctionSep 29, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WERE STRIPPED THREADS ON THE OUTER SHAFT OF THE SYMPHONY SCREWDRIVER. IT WAS BROKEN DURING THE CASE. NO FRAGMENTS WERE GENERATED; THERE WAS ONLY MANGLED METAL ON THE THREAD. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE, SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508338 ↗