SYMPHONY 2020-00-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034530451), received between Feb 1, 2022 and Sep 4, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50609002 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SYMPHONY DRILL GUIDE COULDN'T BE ASSEMBLED ANYMORE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236266 ↗
• MalfunctionJan 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A BRAINLAB NAVIGATED CASE USING EXPEDIUM 5.5 KIT AND SYMPHONY NAVIGATED 3.2 DRILL GUIDE, FOUR SCREWS WERE PLACED IN THE PATIENT. TWO WENT IN WITHOUT COMPLICATION, THE SECOND TWO TOOK LONGER AND SURGEON WASN¿T HAPPY THAT THE PLACEMENT WAS ACCURATE. WITH THE BRAINLAB REP, EACH ITEM'S CALIBRATION WAS CHECKED. IT WAS THE NOTED THAT ALTHOUGH THE DRILL GUIDE WAS STILL VISIBLE TO THE NAVIGATION SYSTEM, IT WAS NOT ACCURATE BY AT LEAST COUPLE OF MM. ON FURTHER EXAMINATION, THE ARRAY HAD SHIFTED SLIGHTLY ON THE INSTRUMENT. FOLLOWING A DISCUSSION WITH SURGEON, IT WAS DECIDED IN FUTURE TO CHECK WITH THE SCRUB TEAM AND REP TO ENSURE THE INSTRUMENT IS STILL ALIGNED BETWEEN EACH USE. SURGEON CHOSE TO REMOVE THE SCREWS AND CONTINUE WITH AN UNINSTRUMENTED FUSION. THE SURGERY WAS PROLONGED BY ONE HOUR EXTRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266596 ↗
• 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 20772152 ↗
• MalfunctionJul 22, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, IT WAS NOT POSSIBLE TO ASSEMBLE THE DRILL GUIDE KNOB PER THE INSTRUCTIONS OF THE SURGICAL TECHNIQUE. THE KNOB WON¿T TURN FURTHER THAN 0. IT SEEMS THAT THE RING/SPRING ARE SOMEHOW STUCK WITHIN THE KNOB. THE ISSUE WAS IDENTIFIED WHILE MOUNTING THE INSTRUMENT AT THE VERY BEGINNING OF THE SURGERY. THERE WAS SURGICAL IMPACT AS ANOTHER INSTRUMENT WAS USED INSTEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) NAV DRILL GUIDE BODY 2.8-3.2MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799592 ↗
• MalfunctionJun 4, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2024, ONE OF THE SYMPHONY DRILL GUIDES JAMMED AND BROKE DURING INITIAL SETUP PREOPERATIVELY. A SECOND SET WAS OPENED, AND THERE WAS NO IMPACT TO THE PROCEDURE OR THE PATIENT. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM DRILL GUIDE ADJUSTABLE BODY 2.8-3.2MM 0-50MM +/- 0.33 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458863 ↗
• MalfunctionFeb 7, 2024Break; Detachment of Device or Device Component; Device-Device Incompatibility; Mechanical Jam; Break; Detachment of Device or Device Component; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT WHILE REMOVING THE APPROXIMATOR FROM THE CLIP, THE HANDLE CAME LOOSE/LOST GLUE. NO PATIENT HARM. NO PATIENT DETAILS AVAILABLE. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659818 ↗
• MalfunctionDec 15, 2022Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT THE INNER WORKINGS OF THE BORE GUIDE/DEPTH LIMITER HAVE A SPRING INSIDE WHICH IS SECURED WITH TWO SMALL BOLTS (LEFT). IN THE CASE OF THE DEFECTIVE DEPTH LIMITER (RIGHT), THOSE BOLTS ARE NO LONGER PRESENT, OR THE SPRING INSIDE HAS EXCEEDED THESE BOLTS. IT WAS DURING THE PREPARATION/INSPECTION OF THE OPERATING THEATRE NURSE (AT THE INSTRUMENT TABLE), BEFORE THE OPERATION! WHEN TRYING TO CONNECT BOTH DRILL GUIDES (NAV DRILL GUIDE BODY) 2.4 AND 3.2 WITH THE DEPTH STOP, IT WAS NOT POSSIBLE TO INSERT THE DEFECTIVE DEPTH STOP IN ONE OF THE TWO DRILL GUIDES. THE CAUSE OF THIS INCIDENT WAS THE DRILL SLEEVE, WHICH WAS WITHOUT A LIMIT (STOP) FOR THE INTERNAL SPRING. THERE WAS NO PATIENT HARM. 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 15987534 ↗
• MalfunctionSep 9, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING SET UP OF INSTRUMENTS, IT WAS DISCOVERED THAT THE CAP PIECE OF THE DRILL GUIDE HAD A FAULTY SPRING INSIDE IT. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM DRILL GUIDE ADJUSTABLE BODY 2.8-3.2MM 0-50MM +/- 0.33. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15390758 ↗
• MalfunctionFeb 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHEN MOUNTING THE SCALE BODY ON THE DRILL GUIDE, THE TEAM STRUGGLED FOR A LONG TIME. IT WOULD NOT SIT ON AS THE INSTRUCTION SAID, AND SOMETHING SEEMED WRONG. THE TEAM FINALLY GAVE UP AND USED THE OTHER ONE ON THE SET. THE FEATHER SEEMED LOOSE AND INCORRECTLY PLACED IN THE PRODUCT. THE TEAM CHECKED WITH STERILE PROCESSING AND CONFIRMED THAT THEY HAD NOT DISASSEMBLED ANYTHING ON THE SCALE BODY AND FOLLOWED THE WASHING INSTRUCTIONS FOR DEPUY SYNTHES. PROCEDURE WAS COMPLETED WITH A DELAY OF FIFTEEN MINUTES. THIS REPORT IS FOR A NAV DRILL GUIDE BODY 2.8-3.2MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486276 ↗
• MalfunctionFeb 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, ONE OF THE INSTRUMENTS IN SYMPHONY SET NEEDED TO BE REPLACED. THE SURGEON NOTICED THAT THE TOOTHED TIP OF THE SYMPHONY DRILL GUIDE WAS SLIGHTLY SPLAYED. UPON INSPECTION, IT APPEARED TO BE NORMAL WEAR AND TEAR WITH NO ISSUE OR IMPACT ON PATIENT CARE. THE TIPS OF THE DRILL GUIDE ARE SPLAYING OUT AND THE DRILL GUIDE NEEDS TO BE REPLACED. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE(1) SYMPHONY OCT SYSTEM DRILL GUIDE ADJUSTABLE BODY 2.8-3.2MM 0-50MM +/- 0.33 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418070 ↗