NA 323.204Recalls & reported problems
Synthes GmbH · 2.0/2.4MM UNIV DRILL GUIDE · Class 1
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 10887587039152), received between Oct 28, 2021 and Jan 11, 2024 — 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
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.
MalfunctionJan 11, 2024Break; Break
IT WAS REPORTED THAT DURING A CASE, THE SURGEON COMPLAINED ABOUT SOME BROKEN INSTRUMENTS, TO BE REPLACED. THERE WAS NO OTHER INFORMATION PROVIDED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.0/2.4MM UNIV DRILL GUIDE. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18492033 ↗MalfunctionJan 11, 2024Break; Break
NO FRAGMENTS WERE GENERATED, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18491620 ↗MalfunctionOct 28, 2021Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION OF FIELD EQUIPMENT, ONE OF THE PLATE CUTTERS AND DRILL GUIDES WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES (1) 2.0/2.4MM UNIV DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12710868 ↗
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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