NA 359.083Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982196910), received between Feb 27, 2019 and Jul 13, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A PROXIMAL HUMERUS FRACTURE WITH MHN (MULTILOC HUMERAL NAIL) IMPLANTS. DURING SURGERY, THE REAMING ROD DID NOT PASS THROUGH A HOLE OF A NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.5MM TI CALIBRATED REAMING ROD/850MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314783 ↗
• MalfunctionJul 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A PROXIMAL HUMERUS FRACTURE WITH MHN (MULTILOC HUMERAL NAIL) IMPLANTS. DURING SURGERY, THE REAMING ROD DID NOT PASS THROUGH A HOLE OF A NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.5MM TI CALIBRATED REAMING ROD/850MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314778 ↗
• MalfunctionMar 6, 2023Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. SINCE THERE WAS RESIDUAL BONE DISLOCATION AT THE END OF THE WOUND OPENING AND DURING NAIL INSERTION, A REAMING ROD IN QUESTION WAS USED TO ENSURE SMOOTH NAIL INSERTION. AFTER CHECKING THE PROGRESS OF NAIL INSERTION, WHEN THE GUIDE ROD THAT WAS PASSING THROUGH THE NAIL WAS ABOUT TO BE PULLED OUT, THE BALL PART OF THE TIP OF THE GUIDE ROD GOT CAUGHT ON THE INSIDE OF THE NAIL OR ON THE CONNECTING SCREW. ONCE THE NAIL WAS UNAVOIDABLY REMOVED. THE TIP OF THE GUIDE ROD MIGHT BE BENT, SO IT WAS CHECKED WHILE IT WAS OUT OF THE BODY BUT COULD NOT SEE ANY BENDING, SO THE SURGEON RETRIEVED THE GUIDE ROD THROUGH THE INSIDE OF THE NAIL FROM THE SIDE WITHOUT THE BALL. THE OTHER GUIDE ROD, WHICH WAS SEPARATELY STERILIZED, WAS PASSED THROUGH THE NAIL OUTSIDE THE BODY AND PASSED SMOOTHLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE OTHER GUIDE ROD. THE SALES REP HAS CONFIRMED THAT THE GUIDE ROD THAT CAUSED THE FAILURE IS THE SAME PART NUMBER AS THE ONE THAT WORKED WITHOUT PROBLEMS AND THAT THE BALL AT THE END OF THE GUIDE ROD THAT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486024 ↗
• MalfunctionFeb 27, 2019Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN SURGERY FOR A DIAPHYSIS FEMUR FRACTURE, THE REAMING ROD WAS BROKEN UPON MILLING. THE DEVICE APPARENTLY WORE AT THE START OF MILLING AND CAME OUT IN TWO PARTS OR SPLIT IN HALF WHEN REMOVED FROM THE FEMUR. THE BROKEN DEVICE WAS CHANGED IN ORDER TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED FOR ABOUT FIVE (5) MINUTES TO CHANGE THE MILLING CUTTER. PATIENT WAS STABLE AND IN GOOD CONDITION AFTER THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) REAMING ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8373777 ↗