MULTILOC 03.019.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982069580), received between Sep 21, 2018 and Jan 21, 2025 — classified as 9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE SURGEON CONNECTED THE PRODUCT TO INSERT THE SCREW-IN SCREW, BUT IT CAME OFF EVERY TIME HE DRILLED. HE HAD TO REDO THE PROCEDURE SEVERAL TIMES, BUT AFTER THE FOURTH OR FIFTH TIME HE WAS ABLE TO GET IT TO WORK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS ASSUMED THAT BECAUSE IT WAS A SMALL SKIN INCISION, THE SOFT TISSUE WAS INTERVENING AND MAKING IT EASIER FOR THE INSTRUMENT TO COME OFF. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21202939 ↗
• MalfunctionJan 21, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE SURGEON CONNECTED THE PRODUCT TO INSERT THE SCREW-IN SCREW, BUT IT CAME OFF EVERY TIME HE DRILLED. HE HAD TO REDO THE PROCEDURE SEVERAL TIMES, BUT AFTER THE FOURTH OR FIFTH TIME HE WAS ABLE TO GET IT TO WORK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT WAS ASSUMED THAT BECAUSE IT WAS A SMALL SKIN INCISION, THE SOFT TISSUE WAS INTERVENING AND MAKING IT EASIER FOR THE INSTRUMENT TO COME OFF. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21202927 ↗
• MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  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) CENT SLV 3.5 TI LCK SCR/4.5 TI MULILC SC THIS IS REPORT 7 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633972 ↗
• MalfunctionDec 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR THE PROXIMAL HUMERUS WITH MULTILOC HUMERAL NAIL. DURING THE SURGERY, THE SURGEON COULD NOT ATTACH THE CENTERING SLEEVE TO THE MULTILOC SCREW. THE SURGERY WAS COMPLETED WITHOUT A DELAY ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS FINISHED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8159754 ↗
• MalfunctionDec 12, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR THE PROXIMAL HUMERUS WITH MULTILOC HUMERAL NAIL. DURING THE SURGERY, THE SURGEON COULD NOT ATTACH THE CENTERING SLEEVE TO THE MULTILOC SCREW. THE SURGERY WAS COMPLETED WITHOUT A DELAY ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS FINISHED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157977 ↗
• MalfunctionDec 12, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR THE PROXIMAL HUMERUS WITH MULTILOC HUMERAL NAIL. DURING THE SURGERY, THE SURGEON COULD NOT ATTACH THE CENTERING SLEEVE TO THE MULTILOC SCREW. THE SURGERY WAS COMPLETED WITHOUT A DELAY ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS FINISHED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157972 ↗
• MalfunctionSep 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OSTEOSYNTHESIS SURGERY FOR PROXIMAL HUMERAL FRACTURE ON (B)(6) 2018, THE CENTERING SLEEVE FOR TITANIUM LOCKING SCREWS AND TITANIUM MULTILOC SCREWS COULD NOT BE CONNECTED TO THE HEAD OF THE MULTILOC SCREW. AFTER FAILING MANY TIMES, THE SURGEON TRIED AGAIN WHILE SEEING THE CONNECTING POINT AND DIRECTION OF THE SCREW UNDER DIRECT VISION. HOWEVER, THE SLEEVE COULD NOT BE ATTACHED TO THE SCREW. THE SURGERY WAS COMPLETED WITH A 30-MINUTE OF SURGICAL DELAY ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS FINISHED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) CENTERING SLEEVE FOR TITANIUM LOCKING SCREWS THIS IS REPORT 3 FO 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900215 ↗
• MalfunctionSep 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING AN OSTEOSYNTHESIS SURGERY FOR PROXIMAL HUMERAL FRACTURE ON (B)(6) 2018, THE CENTERING SLEEVE FOR TITANIUM LOCKING SCREWS AND TITANIUM MULTILOC SCREWS COULD NOT BE CONNECTED TO THE HEAD OF THE MULTILOC SCREW. AFTER FAILING MANY TIMES, THE SURGEON TRIED AGAIN WHILE SEEING THE CONNECTING POINT AND DIRECTION OF THE SCREW UNDER DIRECT VISION. HOWEVER, THE SLEEVE COULD NOT BE ATTACHED TO THE SCREW. THE SURGERY WAS COMPLETED WITH A 30-MINUTE OF SURGICAL DELAY ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS FINISHED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) CENTERING SLEEVE FOR TITANIUM LOCKING SCREWS THIS IS REPORT 2 FO 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900210 ↗
• MalfunctionSep 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OSTEOSYNTHESIS SURGERY FOR PROXIMAL HUMERAL FRACTURE ON (B)(6) 2018, THE CENTERING SLEEVE FOR TITANIUM LOCKING SCREWS AND TITANIUM MULTILOC SCREWS COULD NOT BE CONNECTED TO THE HEAD OF THE MULTILOC SCREW. AFTER FAILING MANY TIMES, THE SURGEON TRIED AGAIN WHILE SEEING THE CONNECTING POINT AND DIRECTION OF THE SCREW UNDER DIRECT VISION. HOWEVER, THE SLEEVE COULD NOT BE ATTACHED TO THE SCREW. THE SURGERY WAS COMPLETED WITH A 30-MINUTE OF SURGICAL DELAY ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS FINISHED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) CENTERING SLEEVE FOR TITANIUM LOCKING SCREWS. THIS IS REPORT 1 FO 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900205 ↗