SYMPHONY 2020-00-120Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM DRILL GUIDE ADJUSTABLE BODY 2.2-2.4mm 0-50mm +/- 0.33 percent · Class 2
All models of SYMPHONY (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medos Symphony adjustable drill guide, a surgical instrument used to help position drills during orthopedic procedures. The 36 reports mostly describe parts breaking, bending or deforming — often springs or drill stops snapping during assembly — plus guides that would not fit together or slipped out of position. No deaths or injuries are reported, and no recalls name this device. Reports fell from 7 in the prior 12 months to 1 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705034530420), received between Apr 1, 2021 and Nov 11, 2025 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Break” (24 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.
Reports received per month
Most reported problems
Device problems
- Break24
- Device-Device Incompatibility8
- Material Deformation6
- Device Slipped2
- Mechanical Jam2
- Detachment of Device or Device Component1
- Inaccurate Information1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 36 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 23523825 ↗MalfunctionApr 2, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CENTER PORTION OF FRENCH BENDER IS LOOSE AND DRILL GUIDE BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751332 ↗MalfunctionApr 2, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CENTER PORTION OF FRENCH BENDER IS LOOSE AND DRILL GUIDE BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751236 ↗MalfunctionApr 2, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CENTER PORTION OF FRENCH BENDER IS LOOSE AND DRILL GUIDE BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751004 ↗MalfunctionApr 2, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CENTER PORTION OF FRENCH BENDER IS LOOSE AND DRILL GUIDE BENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21750714 ↗MalfunctionJan 27, 2025Break; Device Slipped; Break; Device Slipped
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENT BREAK INTO TWO OR MORE PIECES. THIS HAPPENED PRIOR TO A CASE WHEN SETTING UP THE INSTRUMENTS. NO ADVERSE EVENT OCCURRED DUE TO THE BREAKAGE AND NO BROKEN FRAGMENTS RETAINED IN THE PATIENT. NO OTHER MEDICAL INTERVENTION REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21246460 ↗MalfunctionNov 25, 2024Break; Material Deformation; Mechanical Jam; Break; Material Deformation; Mechanical Jam
IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON AN UNKNOWN DATE IN 2024, THERE WAS A DRILL GUIDE WITH A BROKEN DRILL STOP. THERE IS A SPRING MECHANISM IN IT THAT ALREADY FALTERED DURING THE ASSEMBLY. BECAUSE THE STOP KEPT GETTING STUCK DURING TIGHTENING, THE SPRING IN IT STARTED TO DEFORM MORE. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20775808 ↗MalfunctionNov 25, 2024Break; Material Deformation; Mechanical Jam; Break; Material Deformation; Mechanical Jam
IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON AN UNKNOWN DATE IN 2024, THERE WAS A DRILL GUIDE WITH A BROKEN DRILL STOP. THERE IS A SPRING MECHANISM IN IT THAT ALREADY FALTERED DURING THE ASSEMBLY. BECAUSE THE STOP KEPT GETTING STUCK DURING TIGHTENING, THE SPRING IN IT STARTED TO DEFORM MORE. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20772079 ↗MalfunctionJul 1, 2024Break; Break
IT WAS REPORTED THAT ON JUNE 3, 2024, IT WAS DISCOVERED BY THE STERILE SERVICES AT THE HOSPITAL THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM DRILL GUIDE ADJUSTABLE BODY 2.2-2.4MM 0-50MM +/- 0.33 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643735 ↗MalfunctionJun 12, 2024Break; Break
IT WAS REPORTED DURING A SYMPHONY CASE ON MAY 14, 2024, THE 2.2- 2.4MM DRILL GUIDE BROKE. THE INSTRUMENT WAS USED INCORRECTLY BY SCRUB STAFF CAUSING THE SPRING TO BREAK. THEY TRIED TO PULL THE INSTRUMENT APART BEFORE IT GOT BACK TO HAVING "A" IN THE WINDOW CAUSING THE BREAKAGE. THE SPRING BREAKING HAS AFFECTED THE DRILL GUIDE¿S ABILITY TO CHANGE DEPTH. THERE WAS NO DELAY TO THE OPERATION, AND NO PATIENT OUTCOMES WERE AFFECTED AS A RESULT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE SYMPHONY OCT SYSTEM DRILL GUIDE ADJUSTABLE BODY 2.2-2.4MM 0-50MM +/- 0.33 PERCENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19521961 ↗MalfunctionMar 14, 2024Break; Device Slipped; Break; Device Slipped
THERE WAS NO PATIENT IMPACT AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18903162 ↗MalfunctionFeb 5, 2024Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE ASSEMBLY BROKE AND COULDN'T ADJUST DEPTH. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18644618 ↗MalfunctionFeb 5, 2024Break; Break
IT WAS REPORTED THAT THE DRILL GUIDE ASSEMBLY BROKE AND COULDN'T ADJUST DEPTH. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18644524 ↗MalfunctionJan 31, 2024Break; Break
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, A DRILL GUIDE BROKE. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18617209 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED ON JANUARY 11, 2024, THAT THE DRILL SLEEVE CAN NO LONGER BE ASSEMBLED BECAUSE THE DEPTH STOP IS WEDGED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18594823 ↗MalfunctionNov 30, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE DRILL GUIDE ASSEMBLY BROKEN AND CAN'T ADJUST DEPTH. THE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18237953 ↗MalfunctionNov 13, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS DISCOVERED THAT THE INSTRUMENT IN QUESTION COULD NO LONGER BE ASSEMBLED. THE ISSUE WAS DISCOVERED PRE-OP, THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM DRILL GUIDE ADJUSTABLE BODY 2.2-2.4MM 0-50MM +/- 0.33 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18119512 ↗MalfunctionNov 2, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE INSTRUMENT CAN NO LONGER BE ASSEMBLED. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18058172 ↗MalfunctionOct 6, 2023Break; Break
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IN 2023, THE SPRING IN THE DRILL GUIDE IN QUESTION BROKE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT AT THIS TIME. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM DRILL GUIDE ADJUSTABLE BODY 2.2-2.4MM 0-50MM +/- 0.33 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17887090 ↗MalfunctionJul 25, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SCREW OF THE LONG DRILL GUIDE BODY BROKE FOR BOTH. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17389595 ↗MalfunctionJul 25, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SCREW OF THE LONG DRILL GUIDE BODY BROKE FOR BOTH. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17389575 ↗MalfunctionJun 7, 2023Break; Break
THE SPRING IN THE DRILL GUIDE BROKE, INSTRUMENT DISCARDED. NO FRAGMENTS WERE GENERATED. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17082902 ↗MalfunctionJun 7, 2023Break; Break
THE SPRING IN THE DRILL GUIDE BROKE, INSTRUMENT DISCARDED. NO FRAGMENTS WERE GENERATED. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17082885 ↗MalfunctionMay 15, 2023Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SPRING IN THE DRILL GUIDE WAS BROKEN, WHICH NEEDS TO BE REPLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931467 ↗MalfunctionMay 15, 2023Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SPRING IN THE DRILL GUIDE WAS BROKEN, WHICH NEEDS TO BE REPLACED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.2-2.4MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931465 ↗
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- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
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- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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