NA 03.037.001Recalls & reported problems
Synthes GmbH · 16MM PROTECTION SLEEVE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982070173), received between Oct 30, 2024 and Sep 14, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
- Device-Device Incompatibility2
- Corroded1
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Break; Corroded; Material Twisted/Bent
It was reported several instruments were found broken, stripped, and rusted. No patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753248 ↗MalfunctionSep 9, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695085 ↗MalfunctionMay 20, 2026Break; Scratched Material
IT WAS REPORTED THE KEYSTONE SIEVES HAVE SHARP INSTRUMENT HOLDERS THAT SCRATCH SILICONE INSTRUMENT HANDLES OR EVEN BREAK OUT PARTS OF THE SILICONE. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231944 ↗MalfunctionMay 2, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED DURING SURGERY THE DRILL SLEEVE AND THE PROTECTION SLEEVE WERE JAMMING INSIDE EACH OTHER. AFTER INSPECTING THE INSTRUMENTS, IT WAS UNCLEAR WHAT WAS CAUSING THE ISSUE. NO OTHER ISSUES WERE REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY WHILE ANOTHER SET WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21950638 ↗MalfunctionOct 30, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 THE ITEM WAS BROKEN. THIS OCCURRED POST-OPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SUCCESSFUL PATIENT OUTCOME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20566643 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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