NA SD312.003Recalls & reported problems
Synthes GmbH · 2.5MM/3.5MM DOUBLE DRILL SLEEVE · 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 10886982004314), received between Jul 10, 2017 and Oct 12, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break2
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 12, 2018Break; Break
IT WAS REPORTED THAT ON (B)(6) 2018, DURING A HARDWARE REMOVAL, THE DOUBLE DRILL SLEEVE BROKE AS THE TECHNICIAN PLACED THE DRILL AND DOUBLE DRILL SLEEVE ON THE MAYO STAND. THE DOUBLE DRILL SLEEVE WAS NOT IN THE PATIENT WHEN IT BROKE. NO FRAGMENTS WERE GENERATED FROM THE BROKEN DOUBLE DRILL SLEEVE. THERE WAS NO SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 7961051 ↗MalfunctionJul 10, 2017Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE WELDED PART ON A 2.5MM/3.5MM DOUBLE DRILL SLEEVE CAME OFF DURING A PODIATRIC PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2017. ALSO, A 2.5MM DRILL BIT BECAME STUCK INSIDE IT. THERE WAS NO REPORTED SURGICAL DELAY. ANOTHER DRILL BIT WAS AVAILABLE FOR USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THERE ARE 2 DEVICES IN THIS COMPLAINT. THIS REPORT IS 2 OF 2 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6699989 ↗
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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