NA 312.30Recalls & reported problems
Synthes GmbH · 3.5MM/2.5MM INSERT DRILL SLEEVE · Class 1
Data updated Oct 13, 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 10886982187710), received between Mar 26, 2021 and Mar 26, 2021 — 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. How this data works · Data updated Oct 13, 2026.
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.
MalfunctionMar 26, 2021Break; Break
IT WAS REPORTED THAT, THE HELICAL BLADE EXTRACTOR COLD WELDED WHILE USING FOR EXTRACTION OF HELICAL BLADE, INSERTED DRILL SLEEVES BROKE OFF AND PERIARTICULAR PROX HUMERUS PLATE LOCKING HOLE WAS STRIPPED AFTER INSERTING CORTICAL SCREW. SURGICAL DELAY AND PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM/2.5MM INSERT DRILL SLEEVE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11576373 ↗MalfunctionMar 26, 2021Break; Break
IT WAS REPORTED THAT, THE HELICAL BLADE EXTRACTOR COLD WELDED WHILE USING FOR EXTRACTION OF HELICAL BLADE, INSERTED DRILL SLEEVES BROKE OFF AND PERIARTICULAR PROX HUMERUS PLATE LOCKING HOLE WAS STRIPPED AFTER INSERTING CORTICAL SCREW. SURGICAL DELAY AND PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.5MM/2.5MM INSERT DRILL SLEEVE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11575163 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page