Sonoma Orthopedic Products, Inc FIB30130LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816988011491), received between Oct 25, 2017 and Apr 3, 2019 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2019Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED DURING A LEFT ANKLE FRACTURE PROCEDURE, THE PROXIMAL END OF THE FIB30130L FIBULA NAIL BROKE OFF DURING INSERTION AND WAS LEFT INSIDE OF THE FIBULA. THE REP STATED THE FRACTURE WAS SUCCESSFULLY REDUCED AND FIXATED WITH A DISTAL FIBULA PLATE AND SCREWS. THE SEATED DEPTH OF THE IMPLANT WAS 130MM. A 3.22MM WAS USED TO PREP THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: THE REP STATED THAT THE SURGEON ATTEMPTED TO REMOVE THE BROKEN FRAGMENT, BUT NO AVAIL. THE REP CONFIRMED THE REMAINING PORTION OF THE NAIL WAS RETRIEVED AND WILL BE RETURNING FOR EVALUATION. THE BONE WAS PREPPED BY USING A 6.2 DISTAL REAMER AND 3.2 PROXIMAL REAMER. THE REP STATED THAT THE SURGEON HAD TO SWITCH TO THEIR BACK UP PLAN TO MAKE A LARGER INCISION SO THEY COULD PLATE THE FRACTURE. A SECOND FIB30130L WAS NOT BROUGHT IN. THE CASE WAS COMPLETED BY USING AN ANKLE FRACTURE PLATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8479859 ↗
• InjuryMay 24, 2018Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A DISTAL FIBULA FRACTURE PROCEDURE, THE SURGEON DRILLED WITH THE 6.2 MM AND THEN THE 3.2 MM DRILLS FROM THE FIBULOCK DISPOSABLE KIT, PLACED CANNULA, PROCEEDED TO PLACE THE NAIL BY HAND, BUT REALIZED HE SHOULD HAVE DRILLED A BIT FURTHER. HE PULLED THE NAIL BACK OUT OF THE FIBULA WITH EASE, BUT THE TALONS STAYED IN THE FIBULA. HE WAS ABLE TO RE-DRILL AND PLACE A NEW NAIL, WHICH TURNED OUT GREAT, BUT THE EXTRA TALONS STAYED IN THE PATIENT. NO ATTEMPTS WERE MADE TO REMOVE THE TALON/TOP PIECE OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7540109 ↗
• InjuryOct 25, 2017Break

  IT WAS REPORTED DURING A CASE THAT THE 3.0X130MM FIBULA NAIL, LEFT BROKE OFF IN THE FIBULA AS THE NAIL WAS BEING DRIVEN IN. THIS HAPPENED PRIOR TO HAVING TO DEPLOY THE TALONS. THE SURGEON REAMED TO PROPER DEPTH WITH BOTH THE 6.2 AND 3.2 DRILL. THE SURGEON HAD TO CUT THE PROXIMAL PORTION OF THE NAIL TO GET THE NAIL IN. FOLLOW-UP INVESTIGATION: PER SALES REP THE CASE WAS COMPLETED BY CUTTING THE NAIL SHORT AND FINISHING THE CASE PER SURGICAL TECHNIQUE. NO FURTHER ISSUES REPORTED.

  Patient problems: No Information

  MAUDE report 6975638 ↗