SYMPHONY 2020-00-239Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM SHORT DRILL GUIDE ADJUSTABLE BODY 2.2-2.4MM 0-50mm +/- 0.43 percent · Class 1
All models of SYMPHONY (113)
Data updated Oct 16, 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 10705034530741), received between Oct 6, 2022 and Nov 11, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Device-Device Incompatibility1
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.
MalfunctionNov 11, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED TWO DRILL GUIDES WERE NOT ABLE TO BE ASSEMBLED DUE TO A SPRING BEING BROKEN IN THE ADJUSTABLE DRILL GUIDE MEASURING PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523838 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT THE ITEMS WERE IDENTIFIED AS NOT WORKING DURING SURGERY. THE SET HAS 2 OF EACH INSTRUMENT AND ALTERNATIVE WAS USED. THERE WAS NO PATIENT IMPACT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. DRILL GUIDE BODY ADJ 2.2-2.4MM ¿ MECHANISM BROKEN BY ONE PIECE LOST. CANNOT BE FOUND. UNABLE TO USE DURING SURGERY. X15 SELF RETAINING INSERTER - TIP DAMAGED AND NOT HOLDING THE SET SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21629927 ↗MalfunctionOct 6, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT BROKE. THERE WERE NO FRAGMENTS GENERATED, AND THE SURGERY WAS ABLE TO BE DONE WITH A SIMILAR INSTRUMENT. THERE WAS NO DELAY IN SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM SHORT DRILL GUIDE ADJUSTABLE BODY 2.2-2.4MM 0-50MM +/- 0.43 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15552565 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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