SYMPHONY 2020-00-335Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034530772), received between Oct 27, 2021 and Mar 7, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT THE DRILL BITS WERE DULL AND WARPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546653 ↗
• MalfunctionMar 7, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT THE DRILL BITS WERE DULL AND WARPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546649 ↗
• MalfunctionMar 6, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL BITS WERE DULL AND WARPED. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542360 ↗
• MalfunctionMar 6, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL BITS WERE DULL AND WARPED. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542359 ↗
• MalfunctionMar 6, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL BITS WERE DULL AND WARPED. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542358 ↗
• MalfunctionMar 6, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL BITS WERE DULL AND WARPED. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542357 ↗
• MalfunctionMar 6, 2025Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL BITS WERE DULL AND WARPED. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542349 ↗
• MalfunctionOct 27, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN SPINAL PROCEDURE, THE 2.4MM DRILL BIT BROKE DURING USE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.4MM DRILL FOR 3.5MM SCRW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704398 ↗