EVOS 71176002Recalls & reported problems
Smith & Nephew, Inc. · 2.5MM HEX HOLDING SLEEVE 2CM · Class 1
All models of EVOS (190)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556734254), received between May 18, 2021 and Sep 29, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Connection Problem1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2021Break; Break
IT WAS REPORTED THAT (2) 2.5 MM HEX HOLDING SLEEVE 2 CM HAVE BROKEN CAPTURES. IT WAS UNKNOWN IF THIS OCCURRED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12546155 ↗MalfunctionSep 28, 2021Break; Break
IT WAS REPORTED THAT (2) 2.5MM HEX HOLDING SLEEVE 2CM HAVE BROKEN CAPTURES. IT WAS UNKNOWN IF THIS OCCURRED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12544584 ↗MalfunctionMay 19, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED 2.5 MM HEX HOLDING SLEEVE 2 CM DOES NOT CAPTURE. IT IS UNKNOWN IF THE EVENT HAPPENED DURING A SURGICAL PROCEDURE, IF THERE WAS A SURGICAL DELAY, BACKUP DEVICE AVAILABLE OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11850263 ↗MalfunctionMay 18, 2021Connection Problem; Connection Problem
IT WAS REPORTED THAT, A 2.5MM HEX HOLDING SLEEVE 2CM DID NOT TIGHTEN IN ORDER TO ACT AS A CAPTURE FOR SCREWS. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11846205 ↗
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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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