NA 04.130.212Recalls & reported problems
Synthes GmbH · 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 12MM · Class 2 · Implant
Data updated Oct 18, 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 10886982112774), received between Sep 26, 2023 and Sep 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR THIRD AND FOURTH METACARPAL FRACTURE WITH SCREWDRIVER SHAFT, DRILL BIT, VA LOCKING STRAIGHT PLATE AND LOCKING SCREWS. WHILE THE SURGEON WAS DRILLING TO FIX THE VA LOCKING STRAIGHT PLATE, THE DRILL BIT BROKE. FORTUNATELY, THE DRILL BIT COULD BE REMOVED FROM THE BODY, AND THE SURGERY PROCEEDED. NEXT, THE SCREWDRIVER SHAFT BROKE WHEN INSERTING THE LOCKING SCREW. BUT THIS ONE WAS ALSO REMOVED FROM THE BODY. THE SURGEON PROCEEDED WITH THE SURGERY USING A SCREWDRIVER OF THE SAME STANDARD. AFTER THAT, WHEN INSERTING ANOTHER LOCKING SCREW, TWO SCREW HEADS BROKE. THE SURGEON REMOVED ONE LOCKING SCREW, BUT THE OTHER LOCKING SCREW WAS INSERTED IN A GOOD POSITION FOR FIXATION, SO THE SURGEON LEFT IT IN PLACE AND REMOVED THE IMPLANT. THE SURGEON THEN CHANGED TO 2.0MM PLATE AND SCREW AND FIXED IT, COMPLETING THE SURGERY. ALL THAT REMAINS IN THE PATIENT¿S BODY IS A SINGLE SCREW WITH A BROKEN SCREW HEAD. THE SURGEON THOUGHT THE CAUSE OF THE FRACTURE WAS THAT THE PATIENT WAS 19 YEARS OLD AND HAD GOOD BONE QUALITY. THE SURGERY WAS COMPLETED SUCCESSFULLY MORE TH
Patient problems: Insufficient Information
MAUDE report 17819879 ↗
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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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