Sonoma Orthopedic Products, Inc. ST6900Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816988012436), received between Apr 29, 2020 and Apr 29, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2020Material Fragmentation

  ORIGINAL DOS WAS (B)(6) 2018, A FIBULOCK NAIL WAS USED FOR AN ANKLE FRACTURE. UPON VIEWING X-RAYS, THE SURGEON THOUGHT THAT THE NAIL HAD BROKEN AND SO A SECOND SURGERY WAS DONE (B)(6) 2020; HE USED THE CS6910 REMOVAL SCREW FROM THE ST6900 FIB REMOVAL KIT. WHEN ATTEMPTING TO REMOVE THE NAIL, THE THREADS OF THE CS6910 BROKE OFF IN THE NAIL AND THEN THE SCREW BROKE. THE SURGEON DETERMINED THAT THE ORIGINAL NAIL WAS NOT BROKEN, SO THEY DID NOT PROCEED WITH THE REMOVAL. THE ORIGINAL NAIL IS IN THE PATIENT; IT NOW CONTAINS DEBRIS THREADS FROM THE CS6910. UNKNOWN PATIENT INFO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10010810 ↗