MULTILOC 03.019.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982069498), received between Mar 29, 2018 and Aug 3, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114843 ↗
• MalfunctionMay 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE TWO AIMING ARMS INCLUDED IN THE MULTILOC PROXIMAL HUMERAL NAILING SET ARE ALLEGED BY THE CUSTOMER AS CAUSING THE DRILL BIT FOR THE LOCKING SCREW (MULTILOC) TO MISS THE NAIL. THE SURGEON BELIEVES THAT THE AIMING ARM IS OFF AND SHOULD BE REPLACED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142456 ↗
• MalfunctionMay 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PROXIMAL LOCKING SCREW MISSED THE NAIL EVEN THOUGH THE AIMING ARM WAS USED. THE SCREW NEEDED TO BE REMOVED BUT WAS VERY DIFFICULT TO REMOVE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIXTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986062 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BOLT WAS BENT WHEN OPENED. AIMING ARM MISSED NAIL. LOCKING SCREW DID NOT LOCK INTO PLATE AFTER BENT. CALIBRATION WAS OFF FOR TWO DEPTH GAUGE AND TWO (2) 3.5MM VARIABLE ANGLE (VA) DRILL SLEEVES WERE NOT ABLE TO THREAD INTO HANDLE, UNSURE IF THREADS WERE STRIPPED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) AIMING ARM FOR MULTILOC HUMERAL NAIL. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809029 ↗
• MalfunctionFeb 2, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A MULTILOC PROCEDURES, THE DRILL BIT HIT THE NAIL FOR THE POSTERIOR, ANTERIOR AND DIRECT ANTERIOR SCREW. THE SLEEVES WERE TESTED BEFORE AND UNSURE WHAT HAPPENED. PERFECT CIRCLE PROCEDURE WAS PERFORMED PROXIMALLY. THERE WAS A PATIENT DELAY. IT WAS UNSURE THAT THE JIG WAS BENT OR NOT DUE TO ROTATING JIG INTRAOP, BUT SURGEON WANTS EVERYTHING REPLACED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) AIMING ARM FOR MULTILOC HUMERAL NAIL. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632767 ↗
• MalfunctionNov 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SPECTROSCOPIC FRACTURE SURGERY FOR A FRACTURE OF THE UPPER WRIST BONE TRUNK WITH THE PRODUCT IN QUESTION. DURING MHN LONG OPERATION, WHEN ITEM 03.019.013, PROTECTION SLEEVE FOR 13.0/10.0 MULTILOC SCREW, WAS PASSED THROUGH THE B HOLE D HOLE OF THE PRODUCT IN QUESTION, ONLY HALF OF THE SLEEVE WAS PASSED. ITEM 03.019.008, AIMING ARM FOR MULTILOC WAS SUBSTITUTED, AND THE SURGERY PROCEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE AIMING ARM FOR MULTILOC HUMERAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752508 ↗
• MalfunctionOct 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR PROXIMAL HUMERUS FRACTURE WITH THE MULTILOC HUMERAL NAIL AND THE AIMING ARM. BEFORE THE SURGERY, THE SURGEON CHECKED THE DEVICES. WHEN THE SURGEON ASSEMBLED THE DEVICES, A DRILL SLEEVE WAS DEVIATED FROM THE D HOLE OF THE NAIL, AND A DRILL BIT INTERFERED WITH THE HOLE. THE SURGEON TRIED SMALLER NAIL, BUT THE SAME EVENT OCCURRED. THE SURGEON THOUGHT THAT THE AIMING ARM HAD SOME PROBLEM. THE SURGEON PRESSED THE DRILL SLEEVE WITH HIS HAND, AND HE MANAGED TO PASS THE DRILL TO THE D HOLE. THE SURGEON PERFORMED THE SURGERY WITH THE DEVICES, AND THE SURGEON COULD DRILL THE D HOLE SOMEHOW, AND THE SURGERY WAS COMPLETED. THE SAME AIMING ARM WAS USED IN THE SURGERY. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) AIMING ARM FOR MULTILOC HUMERAL NAIL. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227251 ↗
• MalfunctionMar 29, 2018Failure to Align; Failure to Align

  CONCOMITANT DEVICES REPORTED: AIMING ARM KNOB (03.019.030, LOT 8316319, QUANTITY 1), AIMING ARM FOR SHORT NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 2), MULTILOC HUMERAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7383446 ↗