SYMPHONY 2020-00-224Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM LONG DRILL BIT FOR 3.5mm SCREWS 2.4mm · Class 2
All models of SYMPHONY (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034530710), received between Jan 12, 2022 and Jul 25, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SPRING ON THE SYMPHONY DRILL GUIDE BROKE AND THE STOP WILL NOT GO INTO PLACE. THERE WAS A PATIENT INVOLVEMENT. THERE WERE NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) NAV 2.4MM DRILL FOR 3.5MM SCRW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17389235 ↗MalfunctionMar 15, 2022Break; Break
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE DRILL BIT BROKE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SYMPHONY DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13770897 ↗MalfunctionJan 12, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2021, THE DRILL GUIDE ADAPTOR BROKE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) NAV 2.4MM DRILL FOR 3.5MM SCRW. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13238314 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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