EVOS 71174987Recalls & reported problems
Smith & Nephew, Inc. · T6 HOLDING SLEEVE · Class 1
All models of EVOS (190)
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 00885556500644), received between Apr 13, 2021 and May 7, 2024 — classified as 6 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component2
- Connection Problem1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, TWO (2) T6 HOLDING SLEEVE WERE UNABLE TO BE USED DUE TO A BROKEN SPRING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19259354 ↗MalfunctionMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT THE SPRING OF A T6 HOLDING SLEEVE WAS MISSING. SURGERY WAS PERFORMED, WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THIS CAUSED ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13638576 ↗MalfunctionSep 10, 2021Break; Break
IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, A T6 LINEAR DRIVER SHAFT W/ AO QC AND T6 HOLDING SLEEVE BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THIS HAPPENED DURING EXTERNAL OR INTERNAL USE TO PATIENT. HOWEVER, PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12456417 ↗MalfunctionMay 11, 2021Break; Connection Problem; Break; Connection Problem
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A HOLDING SLEEVE DID NOT STAY LOCKED AND THE TIP BROKE ON THE LINEAR DRIVER SHAFT W/ AO QC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11810088 ↗MalfunctionMay 6, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT AFTER A TRAUMA PROCEDURE THE T6 HOLDING SLEEVE HAD THE CAPTURE MECHANISM WORKING INADEQUATELY. THERE WAS NO SIGNIFICANT DELAY AND IT IS UNKNOWN IF A SMITH AND NEPHEW BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11784077 ↗MalfunctionApr 13, 2021Break; Break
IT WAS REPORTED THAT, THE T6 HOLDING SLEEVE SPRING BROKE OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11655865 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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