SportMeds Instruments 05.05.10.0120Recalls & reported problems
Medacta International SA · Cannulated Screwdriver Shaft T25 · Class 1
Data updated Oct 18, 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 07630971281790), received between Sep 2, 2024 and Jun 18, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Joint Laxity1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Fracture; Fracture
THE TIP OF THE CANNULATED SCREWDRIVER SHAFT T25 BROKE DURING SURGERY. NO PIECES LEFT IN THE PATIENT. BACK UP USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284233 ↗MalfunctionNov 15, 2024Fracture; Fracture
THE TIP OF THE CANNULATED SCREWDRIVER SHAFT T25 BROKE BECAUSE THE NITINOL WAS BENT. NO PIECES LEFT IN THE PATIENT. THE SCREWDRIVER HAS BEEN USED IN COMBINATION WITH A COMPETITOR'S NITINOL WIRE.
Patient problems: Joint Laxity
MAUDE report 20693613 ↗MalfunctionOct 24, 2024Fracture; Fracture
THE TIP OF THE CANNULATED SCREWDRIVER SHAFT T25 BROKE DURING ACL SURGERY DURING MECTASCREW C INTRODUCTION INTO THE FEMORAL TUNNEL. A FRAGMENT REMAINED IN THE PATIENT. THE NITINOL GUIDE WAS DEFORMED. MECTASCREW C HAD NO DAMAGE AND HAS BEEN IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20522209 ↗MalfunctionSep 2, 2024Break; Break
THE TIP OF THE CANNULATED SCREWDRIVER SHAFT T25 AND THE MECTASCREW C BROKE, PROBABLY DUE TO MALPOSITIONING OF THE NITINOL WIRE. THE GRAFT WAS UNDAMAGED AND THE SURGEON USED A NEW SCREW AND ANOTHER SCREWDRIVER TO SUCCESSFULLY COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20118027 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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