NA SD312.021Recalls & reported problems
Synthes GmbH · 2.0MM DRILL SLEEVE 42MM LONG · 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 10886982261274), received between Mar 4, 2021 and Mar 5, 2021 — classified as 2 malfunctions.
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
- Appropriate Device Problem Term/Code Not Available2
- Break1
- Material Deformation1
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.
MalfunctionMar 5, 2021Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DRILL SLEEVE TOP HAT BROKE, THE RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) ENTRY REAMER IS DULL, THE DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS AND DRIVE ADAPTOR WITH QC FOR 6.0 SCHANZ SCREWS WERE STRIPPED. THE PERCUTANEOUS DEPTH GAUGE, THE DEPTH GAUGE FOR LOCKING SCREWS, AND THE DEPTH GAUGE FOR CORTEX SCREWS WERE BENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED BUT THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THIS REPORT INVOLVES ONE (1) 2.0MM DRILL SLEEVE 42MM LONG. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11424041 ↗MalfunctionMar 4, 2021Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DRILL SLEEVE TOP HAT BROKE, RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) ENTRY REAMER IS DULL, DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS AND DRIVE ADAPTOR WITH QC FOR 6.0 SCHANZ SCREWS WERE STRIPPED. PERCUTANEOUS DEPTH GAUGE, DEPTH GAUGE FOR LOCKING SCREWS, AND DEPTH GAUGE FOR CORTEX SCREWS WERE BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED BUT THERE WAS A SURGICAL DELAY OF 15 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11413124 ↗
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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