NA 03.019.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982069702), received between May 16, 2019 and Sep 22, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862741 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS WITH A MULTILOC NAIL FOR A FRACTURE OF THE PROXIMAL END OF THE LEFT HUMERUS. WHEN THE PRODUCTS WERE CHECKED BEFORE NAIL INSERTION, THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL IN THE PROXIMAL HOLE. WHEN THE NAIL WAS REMOVED FROM THE DEVICES AND REASSEMBLED, THE INTERFERENCE IN HOLES A AND B WAS RESOLVED, BUT THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL IN HOLES D, F, AND G. DRILLING WAS SUCCESSFULLY DONE WITHOUT INTERFERENCE BETWEEN THE DRILL BIT AND THE NAIL, AND SCREWS WERE ALSO SUCCESSFULLY INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233174 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF INTRAOPERATIVE INTERFERENCE BETWEEN THE DRILL TIP AND THE INTRAMEDULLARY NAIL. DURING THE SURGERY, AFTER INSERTION OF AN INTRAMEDULLARY NAIL AND PROXIMAL FIXATION, DISTAL ANTEROLATERAL SCREW FIXATION WAS PERFORMED. DURING DISTAL POSTEROLATERAL SCREW FIXATION, THE DRILL TIP INTERFERED WITH THE INTRAMEDULLARY NAIL. AFTER INTERFERENCE, BECAUSE OF THE POSSIBILITY OF FORCE ON THE SLEEVE DUE TO SOFT TISSUE TENSION, A SMALL AMOUNT OF SKIN INCISION AND DEPLOYMENT WAS ADDED. ATTEMPTED TO DRILL AGAIN BUT AGAIN THERE WAS INTERFERENCE. THE SURGEON PULLED OUT THE DRILL AND TRIED TO DRILL A HOLE WITH A SMALLER 3.0 MM DIAMETER K-WIRE, BUT THE INTERFERENCE HAPPENED AGAIN. THE CONNECTION BETWEEN THE INTRAMEDULLARY NAIL AND THE HANDLE AND THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WERE CHECKED AGAIN FOR LOOSENESS. THERE WAS NO INTERFERENCE DURING THE DRY CHECK BEFORE INSERTION. WHEN CHECKED FROM THE SIDE WITH THE SLEEVE IN PLACE, IT WAS CLEARLY OBSERVED THAT THE SLEEVE WAS DISPLACED BACKWARD. THE SURGEON CONSIDERED REMOVING THE AIMING ARM AND PERFORMING THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725273 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE PROXIMAL HUMERAL FRACTURE WITH THE INSTRUMENTS AND NAIL IN QUESTION. THE SURGEON CHECKED THE NAIL SIZE TO BE USED BEFORE SURGERY. THE SURGEON WAS PLANNING TO USE A 9.5 MM NAIL, BUT IN THE PREOPERATIVE IMAGE, THE MEDULLARY CAVITY WAS UNEXPECTEDLY SMALL, SO HE USED AN 8.0 MM NAIL. THE INTRAMEDULLARY NAIL WAS INSERTED THROUGH THE GUIDE ROD, BUT THE MEDULLARY CAVITY WAS TOO NARROW TO GET INSIDE. THE SURGEON USED A HAMMER BECAUSE THE NAIL COULD NOT BE INSERTED (SALES ADVISED AGAINST IT. THE HOSPITAL DID NOT HAVE A REAMER). THE NAIL COULD BE INSERTED UP TO THE SPECIFIED POSITION. THE SURGEON INSERTED THREE PROXIMAL SCREWS AND MOVED ON TO INSERT THE DISTAL SCREWS, BUT THE DRILL BIT INTERFERED WITH THE NAIL, AND IT DID NOT GO IN, SO THE SURGEON REMOVED THE DRILL BIT, TAP IT WITH A HAMMER, LET IT GO THROUGH THE INTRAMEDULLARY NAIL, RE-ATTACH IT TO THE DRILL BIT, AND DRILL TO THE OPPOSITE SIDE. AFTER MEASURING, A SCREW WAS INSERTED. BECAUSE THE DRILL BIT INTERFERED ON THE PROXIMAL SIDE AS WELL, THE SAME PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895012 ↗
• InjuryDec 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR PROXIMAL HUMERUS FRACTURE WITH THE MULTILOC HUMERAL NAILING (MHN) SYSTEM. DURING THE DISTAL SCREW INSERTION, THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL AND THE SURGEON HAD DIFFICULTY IN PASSING THE DEPTH GAUGE THROUGH THE DEVICES, BUT HE COULD CONTINUE THE SURGERY AND CLOSE THE INCISION. JUST AFTER THE SURGERY, THE SURGEON CONFIRMED BY X-RAYS THAT THE DISTAL TWO (2) SCREWS WERE NOT PASSED THROUGH THE NAIL. THE SCREWS WERE INSERTED AT POSTERIOR POSITION. THE SURGEON REMOVED THE SCREWS AND TRIED TO RE-INSERT THE SCREWS AGAIN. THE MOST DISTAL SCREW COULD BE INSERTED SUCCESSFULLY, BUT THE OTHER SCREW COULD NOT BE INSERTED BECAUSE THE BONE STATUS WAS BAD DUE TO REPEATED DRILLING AND SCREW INSERTION. FINALLY, ONE (1) SCREW WERE INSERTED AT DISTAL HOLE AND THE SURGEON GAVE UP INSERTING THE OTHER SCREW AND THE SURGERY WAS COMPLETED WITH FORTY (40) MINUTES DELAY. THE SURGEON COMMENTED THAT THE NAIL IS THICK AND OCCUPIED LARGE SPACE AND THE DISTAL SCREW WAS FIXED FIRMLY. SURGEON COMMENTED THAT THE INSERTION I

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

  MAUDE report 10994472 ↗
• MalfunctionMay 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON APRIL 17, 2019 DURING AN INSPECTION AT STERILE PROCESSING DEPARTMENT, THE INSERTION HANDLE, AIMING ARM, CONNECTING SCREW, AIMING ARM KNOB, THREE (3) DRILL SLEEVE AND THREE (3) PROTECTION SLEEVE OF THE MULTILOC HUMERAL NAIL INSTRUMENTS DID NOT ACCURATELY TARGET HOLES IN NAIL WITH DRILL BITS. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8615546 ↗