NA 03.614.011Recalls & reported problems
Synthes GmbH · DRILL GUIDE WITH GRADUATION FOR 3.2MM DRILL BIT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034714837), received between Jul 31, 2023 and Aug 1, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2023Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT WHEN MOUNTING THE GUIDE, THE DRILL SLEEVE BREAKS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILLSLEEV W/SCAL F/DRILL BIT Ø3.2 NO. 0 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17432401 ↗MalfunctionJul 31, 2023Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2023, THAT WHEN MOUNTING THE GUIDE, THE DRILL SLEEVE BREAKS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILLSLEEV W/SCAL F/DRILL BIT Ø3.2 NO. 0. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17426786 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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