NA 03.111.041Recalls & reported problems
Synthes GmbH · HOLDING SLEEVE HANDLE FOR COMPRESSION/DISTRACTION · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982072399), received between Jan 5, 2026 and Jan 5, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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 Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE HOLDING SLEEVE HANDLE WAS NOT LOOSENING THE HOLDING SLEEVES WHILE USING THE FOOT DISTRACTOR DEVICE. SURGERY WAS ONLY SLIGHTLY DELAYED, IT HAPPENED NEAR COMPLETION OF THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23962293 ↗
Other INSTRUMENT, COMPRESSION devices
- ATTUNE 2545-01-042Depuy (Ireland) · INSTRUMENT, COMPRESSION153 reports
- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-550Depuy (Ireland) · INSTRUMENT, COMPRESSION54 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 reports
- ATTUNE 2545-05-552Depuy (Ireland) · INSTRUMENT, COMPRESSION27 reports
- NA 03.211.400Synthes GmbH · INSTRUMENT, COMPRESSION25 reports
- VIPER PRIME 286750083Medos International Sàrl · INSTRUMENT, COMPRESSION18 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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