NA 03.127.002Recalls & reported problems
Synthes GmbH · 2.8MM VARIABLE ANGLE DOUBLE DRILL GUIDE WITH CONE · Class 1
Data updated Oct 18, 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 10886982075024), received between Jan 17, 2025 and Jan 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON 1/08/2025 WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS SALES REP NOTICED THAT THERE WERE SEVERAL INSTRUMENTS THAT WERE DAMAGED. 1. PRODUCT # 511.744, LOT # UNKNOWN, QUANTITY 1. THIS PIECE WAS DAMAGED BASED UPON THE SCREWDRIVER TIP, NOT BEING ABLE TO BE PUT INTO THE TORQUE LIMITER. THE LOT NUMBER IS UNKNOWN FOR THIS ITEM SINCE IT WAS DISCARDED BY THE FACILITY. 2. PRODUCT # 03.900.360, LOT # UNKNOWN, QUANTITY 3. THESE THREE ITEMS ARE T 15 SCREWDRIVERS, AND THE TIPS OF THE SCREWDRIVERS WERE STRIPPED AND UNABLE TO HOLD A SCREW ON IT. A LOT NUMBERS FOR THESE ITEMS ARE UNKNOWN SINCE THEY WERE ALL THREE DISCARDED BY THE FACILITY. 3. PRODUCT # 03.127.002, LOT # UNKNOWN, QUANTITY 1. THIS ITEM WAS A DRILL CONE FOR A VARIABLE ANGLE PLATE, AND THE CONE TIP WAS BENT, AND IS UNABLE TO BE LOCKED INTO A PLATE. THE LOT NUMBER FOR THIS DEVICE IS UNKNOWN SINCE THE ITEM WAS DISCARDED BY THE FACILITY. 4. PRODUCT # 03.127.006, LOT # UNKNOWN, QUANTITY 1. THIS ITEM IS A VARIABLE ANGLE GUIDE, AND THE TIP OF THE ANGLE GUIDE HAS BEEN SMASHED, AND THE DRILL IS UNABLE TO PASS THROUGH IT. THE LOT NUMBER ON THIS DEVICE IS UNKNOWN SINCE IT WAS DISCARDED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179295 ↗
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- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
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- 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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