Sonoma Orthopedic Products, Inc OutriggerRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816988011743), received between Apr 1, 2021 and Oct 24, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2022Break

  ON 10/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN IN6000 OUTRIGGER TIP BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 15657304 ↗
• MalfunctionApr 1, 2021Break

  IT WAS REPORTED BY THE SALES REP, THAT DURING AN ANKLE FRACTURE PROCEDURE, WHILE THE SURGEON WAS USING THE FIBULOCK NAIL, THE NAIL WAS INSERTED, TALONS ACTUATED AND DURING DRILLING OF THE DISTAL SCREWS THROUGH THE JIG, THE JIG WAS ROTATING CAUSING THE DRILL TO MISS THE SCREW HOLE IN THE NAIL AND A PIECE OF THE DRILL BROKE OFF IN THE PATIENT, AS WELL AS A PIECE OF THE BASE WHERE THE NAIL SCREWS ON TO THE JIG. THE DRILL BIT PIECE WAS UNABLE TO BE REMOVED AND WAS LEFT IN PATIENT. THE PIECE THAT BROKE OFF THE JIG WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11602468 ↗