NA 03.019.021Recalls & reported problems
Synthes GmbH · 5.8MM/2.8MM DRILL SLEEVE FOR 03.019.019 · 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 10886982069603), received between Jul 21, 2022 and Feb 2, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
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.
MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A MULTILOC PROCEDURES, THE DRILL BIT HIT THE NAIL FOR THE POSTERIOR, ANTERIOR AND DIRECT ANTERIOR SCREW. THE SLEEVES WERE TESTED BEFORE AND UNSURE WHAT HAPPENED. PERFECT CIRCLE PROCEDURE WAS PERFORMED PROXIMALLY. THERE WAS A PATIENT DELAY. IT WAS UNSURE THAT THE JIG WAS BENT OR NOT DUE TO ROTATING JIG INTRAOP, BUT SURGEON WANTS EVERYTHING REPLACED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.8MM/2.8MM DRILL SLEEVE FOR 03.019.019. THIS IS REPORT 6 OF 9 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18633189 ↗MalfunctionJul 21, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE CENTERING SLEEVE FOR MULTILOC HUMERAL NAIL 3.5 LOCKING SCREWS WOULD NOT ALLOW THE DRILL BIT TO GO THROUGH. SCREWS WERE NOT ABLE TO BE INSERTED. NO FRAGMENTS WERE GENERATED. THERE WAS A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.8MM/2.8MM DRILL SLEEVE FOR 03.019.019. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15076747 ↗
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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