SYMPHONY 2020-00-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034532615), received between Jun 7, 2021 and Jan 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE HANDLE STOPPED WORKING DURING SCREW INSERTION. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118102 ↗
• MalfunctionAug 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BEFORE SURGERY ON (B)(6) 2024, WHEN THE AO HANDLES IN QUESTION WERE CLEANED AND STERILIZED IN THE CENTRAL SUPPLY ROOM, A BLOOD-LIKE DIRT WAS FOUND ON THEM, AND THEIR USE WAS STOPPED. ANOTHER HANDLE WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM AO HANDLE, MEDIUM WITH RATCHET THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044074 ↗
• MalfunctionMay 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE SYMPHONY SCREW DRIVER HANDLE AND DRIVER WERE DIFFICULT TO DISCONNECT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) AO HANDLE MEDIUM W RATCHET. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19366968 ↗
• MalfunctionMar 24, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE RATCHET HANDLE DIDN'T WORK (ROTATE) AS WAS SUPPOSED. IT WAS WORKING AS A REGULAR HANDLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THERE APPEARS TO BE FOREIGN SUBSTANCE BETWEEN THE PULL RELEASE AO COUPLING AND THE RATCHET MECHANISM. THIS REPORT IS FOR ONE (1) AO HANDLE MEDIUM W RATCHET THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612462 ↗
• MalfunctionJun 7, 2021Corroded; Device-Device Incompatibility; Corroded; Device-Device Incompatibility

  THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950377 ↗
• MalfunctionJun 7, 2021Corroded; Device-Device Incompatibility; Corroded; Device-Device Incompatibility

  THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950308 ↗