NA 388.393Recalls & reported problems
Synthes GmbH · DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT · Class 1
Data updated Oct 13, 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 10705034772738), received between Oct 22, 2018 and Aug 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SPRING BROKE OFF THE DRILL GUIDE. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) THIS IS REPORT 1 OF 1 FOR COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20033667 ↗MalfunctionAug 27, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANED SET AT FIELD STOCKING LOCATION (FSL), IT WAS OBSERVED THAT A DRILL GUIDE WITH GRADUATION HAD A MISSING PIECE AND HAS BEEN QUARANTINED. THERE WERE NO SURGICAL PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8936234 ↗MalfunctionOct 22, 2018Break; Break
THIS REPORT IS FOR ONE (1) DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT.
Patient problems: No Patient Involvement
MAUDE report 7990911 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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