NA SD314.052Recalls & reported problems
Synthes GmbH · 3.5MM DRILL SLEEVE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982305909), received between Oct 1, 2024 and Nov 25, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Material Integrity Problem6
- Contamination /Decontamination Problem3
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2024Break; Contamination /Decontamination Problem; Material Integrity Problem; Break; Contamination /Decontamination Problem; Material Integrity Problem
IT WAS REPORTED THAT THE ITEM WAS CHIPPING AND DAMAGED, UNABLE TO STERILIZE.
Patient problems: Insufficient Information
MAUDE report 20776580 ↗MalfunctionNov 25, 2024Break; Contamination /Decontamination Problem; Material Integrity Problem; Break; Contamination /Decontamination Problem; Material Integrity Problem
IT WAS REPORTED, THAT THE ITEM WAS CHIPPING AND DAMAGED. UNABLE TO STERILIZE.
Patient problems: Insufficient Information
MAUDE report 20775982 ↗MalfunctionNov 25, 2024Break; Contamination /Decontamination Problem; Material Integrity Problem; Break; Contamination /Decontamination Problem; Material Integrity Problem
IT WAS REPORTED THAT THE ITEM WAS CHIPPING AND DAMAGED, UNABLE TO STERILIZE.
Patient problems: Insufficient Information
MAUDE report 20774364 ↗MalfunctionOct 1, 2024Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE INSTRUMENT HAD CHIPPING AND WAS DAMAGED. IT WAS UNABLE TO STERILIZE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE UNK - GUIDE/COMPRESSION/K-WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20347659 ↗MalfunctionOct 1, 2024Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE INSTRUMENT HAD CHIPPING AND WAS DAMAGED. IT WAS UNABLE TO STERILIZE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE UNK - GUIDE/COMPRESSION/K-WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20346647 ↗MalfunctionOct 1, 2024Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE INSTRUMENT HAD CHIPPING AND WAS DAMAGED. IT WAS UNABLE TO STERILIZE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE UNK - GUIDE/COMPRESSION/K-WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20346500 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page