NA 312.46Recalls & reported problems
Synthes GmbH · 4.5MM/3.2MM DOUBLE DRILL SLEEVE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982187772), received between Oct 12, 2018 and Jun 26, 2020 — classified as 3 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
- Device-Device Incompatibility1
Patient problems
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE. WHILE USING A NEW DRILL BIT, THE DRILL BIT QUICK COUPLING WAS LODGED IN DRILL GUIDE. THERE WERE NO FRAGMENTS GENERATED. PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10201875 ↗MalfunctionMar 29, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND OUT THAT A SCREWDRIVER SHAFT, DRILL SLEEVE, AND TREPHINE FOR A BONE HARVESTING SET WAS BROKEN. IT WAS OBSERVED AT THE STERILE PROCESSING DEPARTMENT(SPD). PARTS ARE IMMEDIATELY TAKEN OUT OF CIRCULATION SO THE PARTS ARE NO LONGER IN THE OPERATING ROOM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.5MM/3.2MM DOUBLE DRILL SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8466687 ↗MalfunctionOct 12, 2018Break; Break
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE A DOUBLE DRILL SLEEVE WAS DAMAGED. THE TEETH ON 4.5MM DISTAL END ARE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 7960901 ↗
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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