PANGEA 542034Recalls & reported problems
Stryker GmbH · Torque Limiting T-Handle, AO · Class 1
All models of PANGEA (53)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327614787), received between Oct 15, 2024 and Oct 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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
- Use of Device Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING A PROCEDURE AN ISSUE WAS OBSERVED WITH A PANGEA T15 SHORT SCREWDRIVER SHAFT WHILE USING A TORQUE LIMITER TO PLACE LOCKING SCREWS IN A PROXIMAL HUMERUS PLATE. AFTER SUCCESSFULLY PLACING 3-5 SCREWS, THE TIP OF THE SCREWDRIVER SHAFT TWISTED, LEAVING SMALL METAL FRAGMENTS IN THE SCREW HEAD. DESPITE A BRIEF 3-5 MINUTE SURGICAL DELAY TO ATTEMPT REMOVAL OF THE FRAGMENTS USING A CURETTE AND BONE HOOK, SOME DEBRIS REMAINED IN THE PATIENT. THE SURGEON EXPRESSED CONCERN THAT A PIECE OF THE DRIVER HEAD MAY HAVE COLD-WELDED TO THE SCREW, POTENTIALLY COMPLICATING FUTURE REMOVAL OF THE PLATE. LONG-TERM COMPLICATIONS MAY ARISE IF THE SCREW HEAD IS DEFORMED, WHICH WOULD REQUIRE MORE SPECIALIZED EQUIPMENT, SUCH AS A CARBIDE DRILL BIT OR MIDAS REX, FOR REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 20456544 ↗
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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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