NA 04.211.032Recalls & reported problems
Synthes GmbH · 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 32MM · Class 2 · Implant
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 10886982119087), received between Feb 13, 2023 and Feb 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE SPECTROSCOPIC FRACTURE SURGERY FOR DISTAL COMMISSURAL FRACTURE OF THE HUMERUS WITH THE PRODUCTS IN QUESTION. SCREW INSERTION WAS PERFORMED AFTER DRILLING WITH A FUNNEL-SHAPED SLEEVE IN A VA 2.7 HOLE, BUT DID NOT LOCK. THAT SCREW IN QUESTION WAS REMOVED AND ANOTHER HOLE WAS USED TO FIX THE PLATE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SCREW THAT REMOVED HAD SCRATCHES ON IT. INSERTING THE REMOVED SCREW INTO THE PLATE SAMPLE LOCKED IT WITHOUT ANY PROBLEM. IT IS INFERRED THAT THE LOCKING MECHANISM OF THE HOLE FAILED DUE TO THE GRIPPING WHEN THE FUNNEL-SHAPED SLEEVE WAS INSTALLED. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 32MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16361997 ↗
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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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