NA 03.600.006Recalls & reported problems
Synthes GmbH · PLATE HOLDING DRILL GUIDE- SINGLE BARREL/FIXED ANGLE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034711799), received between Jan 29, 2019 and Jan 29, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2019Break; Break
IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON (B)(6) 2019, A PLATE HOLDING DRILL GUIDE BROKE APART WHILE TESTING IT. THE SALES CONSULTANT STATED THAT THERE WAS NOT ANY FORCE APPLIED TO IT. THEY DO NOT KNOW IF IT SUSTAINED A BLOW AND JUST BARELY CLUNG TOGETHER UNTIL THAT MOMENT. THE SALES CONSULTANT SQUEEZED IT WHEN TESTING THE LOCK FUNCTION OF THIS INSTRUMENT. ALSO, IT WAS NOTICED THAT THE THREADS ON THE DISTAL END OF THE INNER SHAFT OF THE SCREW REMOVAL TOOL WERE DAMAGED. THE INNER SHAFT WOULD NOT SCREW INTO A SCREW. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: EXTRACTION SCREWDRIVER (PART #: 352.311, LOT #: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR ONE (1) PLATE HOLDING DRILL GUIDE- SINGLE BARREL/FIXED ANGLE THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8286372 ↗
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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