NA 392.964Recalls & reported problems
Synthes GmbH · 4-POSITION DRILL GUIDE HANDLE · Class 1
Data updated Oct 16, 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 10886982198891), received between May 12, 2025 and May 12, 2025 — classified as 2 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. 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
- Break2
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.
MalfunctionMay 12, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6), 2025 WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS IT WAS NOTICED THAT THERE WERE SOME INSTRUMENTS THAT WERE DAMAGED AND IN NEED OF BEING REPLACED. THERE WAS ALSO GRAPHIC CASES THAT WAS BROUGHT INTO ATTENTION BY THE FACILITY THAT NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT FOR ANY OF THESE ITEMS. THE DRILL GUIDES ARE BENT AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002281 ↗MalfunctionMay 12, 2025Break; Break
IT WAS REPORTED THAT ON (B)(6), 2025 WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS IT WAS NOTICED THAT THERE WERE SOME INSTRUMENTS THAT WERE DAMAGED AND IN NEED OF BEING REPLACED. THERE WAS ALSO GRAPHIC CASES THAT WAS BROUGHT INTO ATTENTION BY THE FACILITY THAT NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT FOR ANY OF THESE ITEMS. THE DRILL GUIDES ARE BENT AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002256 ↗
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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