PASS LP A01130250Recalls & reported problems
Medicrea International · T20 SCREWDRIVER SHAFT · Class 1
All models of PASS LP (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03613720210757), received between Jun 10, 2024 and Dec 11, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A NORMAL CHECK-IN, THE TIP OF THE DRIVER WAS OBSERVED TO BE ROUNDING OFF. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23786061 ↗MalfunctionSep 4, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT BOTH THE INSTRUMENT TORX SHAFT AND THE DRIVER WERE STRIPPED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962265 ↗MalfunctionJun 10, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY FOR EXTENSION DUE TO VERTEBRAL FRACTURE. IT WAS REPORTED THAT WHEN REMOVING A CROSSLINK IN A REVISION SPINE PROCEDURE, THE TIP OF THE T20 DRIVER SHEARED OFF IN THE IMPLANT. THE SHARD WAS RECOVERED AND WAS NOT LEFT IN THE PATIENT. A SECOND DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19496346 ↗
Other Screwdriver devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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