MULTILOC 04.019.270SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982090102), received between May 17, 2021 and Mar 14, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THAT SUPPORT IS PROVIDED FOR PLACEMENT OF A MULTILOCK NAIL IN THE LEFT UPPER LIMB. DURING THE PROCEDURE, IT WAS DETERMINED THAT THE MEASUREMENT CORRESPONDS TO A NAIL 8.5 X 270. WHEN PLACED, IT SHOWED SIGNS OF LOOSENING IN THE FRAME AND CONNECTION SCREW. WHEN TRYING TO LOCK, IT WAS NOTICED THAT IT DID NOT MATCH AND THAT IT WAS LOOSE. THE NAIL IS REMOVED A LITTLE TO CHECK ITS CONNECTION AND FOUND TO BE BROKEN IN ITS PROXIMAL PART, WHICH DID NOT PROVIDE STABILITY. IT WAS DECIDED TO CHANGE THE NAIL FOR ONE OF THE SAME SIZE, BUT OF A DIFFERENT DIAMETER. THERE WAS A SURGICAL DELAY OF APPROXIMATELY TWO (2) HOURS AND THIRTY (30) MINUTES. A LEFT IMPLANT 7X 270 WAS PLACED AND DISTAL AND PROXIMAL LOCKS WERE MADE. THIS REPORT INVOLVES ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757284 ↗
• MalfunctionMar 11, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THAT WHILE IMPACTING THE HN MULTILOC Ø 8 NAIL IN THE PROXIMAL PART, IT WAS DAMAGED AND BENT IN THE PART WHERE IT CONNECTS TO THE AIMING ARM. IT WAS DECIDED TO CHANGE IT FOR THE HN MULTILOC Ø 7 NAIL. WHEN THE ASSISTANT OPENED THE SEALED BOX, IT CAME WITH THE METAL PACKAGING OPEN, SO FACTORY STERILITY WAS NO LONGER GUARANTEED. DUE TO THIS SETBACK AND DUE TO THE URGENCY OF THE SPECIALIST TO GO OUT FOR ANOTHER PROCEDURE, THE PATIENT WAS NOT FITTED WITH ANY DEVICE FOR FIXATION, SO THIS WEEKEND A SECOND SURGERY IS PLANNED TO PERFORM THE OSTEOSYNTHESIS. THIS REPORT INVOLVES ONE (1) 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13740374 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL SURGERY OF MULTILOC HUMERAL NAIL DUE TO NON-UNION. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 8.5 TI MULTILOC HUM NL LFT/CANN/270-S. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11833055 ↗