NA 03.168.012Recalls & reported problems
Synthes GmbH · DRILL STOP · Class 1
Data updated Oct 18, 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 10886982274533), received between Aug 12, 2025 and Aug 13, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility3
- Material Twisted/Bent3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT/ARE BUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22798600 ↗MalfunctionAug 13, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT/ARE BUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22798597 ↗MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT / ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790365 ↗
Other CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY devices
- EXPEDIUM 279712580Medos International Sàrl · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY69 reports
- AESCULAP MD610Aesculap, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- ENDOPATH TT012Ethicon Endo-Surgery, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY47 reports
- NA 03.168.013Synthes GmbH · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY37 reports
- NA 214120Medos International Sàrl · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Monoject 8881540111Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY19 reports
- MOSS 279712500Depuy Spine, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY12 reports
- Monoject 8881540133Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY10 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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