NA 03.111.039Recalls & reported problems
Synthes GmbH · 1.8MM COMBINATION DRILL GUIDE F/VA-LOCKING AND STANDARD · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982072375), received between Dec 29, 2020 and Aug 31, 2026 — classified as 4 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
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519104 ↗MalfunctionJan 18, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRILL GUIDE BROKE AND WAS THROWN AWAY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 1.8 COMBINATION DRILL GUIDE F/VAL & STD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18534201 ↗MalfunctionJan 4, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 11, 2023, THE INSTRUMENTS WERE NOTED TO BE BROKEN AND NEEDED TO BE REPLACED. THE ISSUE WAS NOTED POSTOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 1.8MM COMBINATION DRILL GUIDE F/VA-LOCKING AND STANDARD. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18442737 ↗MalfunctionDec 29, 2020Material Deformation; Material Deformation
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE, THE GUIDE WAS BENT AND UNABLE TO INSERT INTO THE PLATE PROPERLY. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.8MM COMBINATION DRILL GUIDE F/VA-LOCKING AND STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11089555 ↗
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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