Sonoma Orthopedic Products, Inc ST6100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816988011989), received between Jun 14, 2018 and Nov 7, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2018Break; Material Separation

  IT WAS REPORTED THAT DURING AN ANKLE FX /FIBULOCK PROCEDURE, THE 3.2 CANNULATED REAMER THAT¿S INCLUDED IN THE STANDARD PROCEDURE PACK, ST6100, BROKE IN HALF WHEN IT WAS UP THE FIBULA. THIS OCCURRED AS THE SURGEON WAS REAMING FOR THE NAIL. THE SURGEON TRIED TO GET IT OUT FOR SOME TIME, HOWEVER WAS UNSUCCESSFUL IN RETRIEVING THE BROKEN FRAGMENT. HE ENDED UP USING A PLATE INSTEAD AND LEFT THE REAMER IN THE PATIENT¿S BONE. IN DOING SO, AN EXTRA INCISION WAS MADE. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: Device Embedded In Tissue or Plaque; Tissue Damage

  MAUDE report 8047249 ↗
• InjuryOct 1, 2018Material Fragmentation; Nonstandard Device

  IT WAS REPORTED THAT DURING A FIBULOCK ANKLE ARTHROSCOPY PROCEDURE, THE SURGEON WAS DRILLING IN THE CANAL WITH THE 3.2MM DRILL BIT THAT IS INCLUDED IN THE ST6100, STANDARD PROCEDURE PACK. THE DRILL GOT UP THROUGH THE FRACTURE SITE AND THE SURGEON STOPPED DRILLING TO GET AN IMAGE. WHEN THE DRILL WAS RESTARTED, THE DRILL BIT BROKE. MOST OF THE FRAGMENTS WERE RETRIEVED HOWEVER, ONE FRAGMENT REMAINED. THE CASE WAS COMPLETED WITH A DRILL FROM A SECOND STANDARD PROCEDURE PACK, ST6100. THE SURGEON USED THE UNBROKEN DRILL BIT AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922735 ↗
• InjuryOct 1, 2018Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A FIBULOCK ANKLE ARTHROSCOPY PROCEDURE, THE SURGEON WAS DRILLING IN THE CANAL WITH THE 3.2MM DRILL BIT THAT IS INCLUDED IN THE ST6100, STANDARD PROCEDURE PACK. HE STOPPED HALFWAY TO SNAP AN X-RAY AND WHEN HE RESTARTED THE DRILL AND BEGAN TO DRILL AGAIN, THE DRILL BIT SHEARED APART. MOST OF THE FRAGMENTS WERE RETRIEVED; HOWEVER, ONE FRAGMENT REMAINED. THE SURGEON DECIDED TO LEAVE THE FRAGMENT AS IS. THE FRAGMENT WAS APPROX. 1CM IN LENGTH. X-RAYS WERE TAKEN WERE BUT ARE NOT AVAILABLE. A SECOND ST6100, STANDARD PROCEDURE PACK, WAS OPENED AND THE 3.2MM DRILL WAS USED TO COMPLETE THE CASE WITH NO OTHER ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922712 ↗
• InjuryOct 1, 2018Break; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A FIBULAR FRACTURE PROCEDURE, THE SURGEON WAS ATTEMPTING TO ATTEMPTING TO FIXATE WITH A FIBULOCK NAIL. UPON REAMING WITH THE 3.2 REAMER, THE REAMER BROKE OFF INTO THE FIBULAR CANAL. HE HAD STARTED THE REAMER BY HAND BECAUSE HE WAS WEARY AFTER THE GOLD WIRE BROKE UPON INITIAL INSERTION. HE THEN PUT IT ON POWER. ONCE ON POWER IT SNAPPED ALMOST INSTANTANEOUSLY. THE REAMER BROKE RIGHT AT THE BASE OF THE FLOOTS. THE SURGEON ATTEMPTED TO RETRIEVE THE BROKEN REALER WITH VARIOUS GRASPERS BUT WAS UNSUCCESSFUL. THE SURGEON WAS UNABLE TO RETRIEVE THE REAMER FRAGMENT AND HAD TO LEAVE THE REAMER IN THE FIBULA AND PLATED OVER THE TOP. A SUCCESSFUL REDUCTION AND PLATING OF FRACTURE WAS COMPLETED WITH THE BROKEN REAMER LEFT INSIDE BONE. ADDITIONAL INFORMATION PROVIDED 9/11/2018: THE SURGEON HAD TO MAKE AN UNPLANNED INCISION TO PLACE THE PLATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7922178 ↗
• InjuryJun 14, 2018Fracture

  IT WAS DISCOVERED DURING MONTHLY MAUDE REVIEW THAT A FACILITY HAD REPORTED THE FOLLOWING INCIDENT: "PATIENT WAS UNDERGOING SURGERY, ON (B)(6) 2018, FOR DISPLACED FRACTURE OF LATERAL MALLEOLUS OF LEFT FIBULA. WHILE SURGEON WAS USING A REAMER TO REAM THE FIBULAR NAIL THE DRILL BIT EMBEDDED INTO THE BONE AND WAS UNRECOVERABLE AFTER SEVERAL ATTEMPTS. SURGEON LEFT IT IN THE BONE. PATIENT HAS RECOVERED WITH NO LONG TERM EFFECTS NOTED." MAUDE REPORT DOES NOT CONTAIN FACILITY OR REPORTER'S NAME OR CONTACT INFORMATION. NO FOLLOW UP POSSIBLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7600211 ↗