EVOS 71174988Recalls & reported problems
Smith & Nephew, Inc. · T7 HOLDING SLEEVE · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556500699), received between May 22, 2019 and Feb 3, 2025 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Loose or Intermittent Connection3
- Detachment of Device or Device Component1
- Failure to Clean Adequately1
- Incomplete or Inadequate Connection1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2025Break; Mechanical Problem; Failure to Clean Adequately; Break; Mechanical Problem; Failure to Clean Adequately
IT WAS REPORTED THAT DURING TRAUMA SURGERY, ONE (1) T7 HOLDING SLEEVE BROKE WHILE PUTTING IN SCREWS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21291199 ↗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) T7 HOLDING SLEEVE WERE UNABLE TO BE USED DUE TO A MISSING 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 19259378 ↗MalfunctionMar 1, 2022Break; Break
IT WAS REPORTED THAT, THE SPRING INSIDE THE T7 HOLDING SLEEVE BROKE OFF. AS THIS HAPPENED DURING THE SET UP OF AN INTERNAL FIXATION SURGERY, THE PATIENT WAS NOT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13638854 ↗MalfunctionSep 9, 2021Break; Break
IT WAS REPORTED THAT, DURING THE SET UP FOR AN UNKNOWN SURGERY, IT WAS NOTICED THAT THERE WAS A BROKEN SPRING INSIDE THE T7 HOLDING SLEEVE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450672 ↗InjuryMay 5, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT, DURING A IM NAIL, THE T-HANDLE SNAPPED IN HALF ((B)(4)), THE T7 HOLDING SLEEVE NO LONGER CAPTURES (B)(4), AND THE SCREW DEPTH GAUGE BROKE ((B)(4)) INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITH A DELAY OF FEWER THAN 30 MINUTES USING A S&N BACK UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11780048 ↗InjuryMay 5, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT, DURING A IM NAIL, THE T-HANDLE SNAPPED IN HALF ((B)(4)), THE T7 HOLDING SLEEVE NO LONGER CAPTURES (B)(4), AND THE SCREW DEPTH GAUGE BROKE (B)(4) INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITH A DELAY OF FEWER THAN 30 MINUTES USING A S&N BACK UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11780011 ↗MalfunctionMay 5, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT, DURING A IM NAIL, THE T-HANDLE SNAPPED IN HALF (CASE (B)(4)), THE T7 HOLDING SLEEVE NO LONGER CAPTURES (B)(4), AND THE SCREW DEPTH GAUGE BROKE (B)(4) INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITH A DELAY OF FEWER THAN 30 MINUTES USING A S&N BACK UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11779776 ↗MalfunctionFeb 23, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT, THE T7 HOLDING SLEEVE DOES NOT HOLD THE SCREW. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11366670 ↗MalfunctionMay 22, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY THE TIP OF DRIVER BROKE OFF IN SCREW HEAD. THE TIP WAS RETRIEVED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE OR A DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8634426 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.