MULTILOC 04.019.028SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982089717), received between Oct 2, 2023 and Oct 2, 2023 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K103002); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR HUMERUS FRACTURE WITH MHN SCREWS AND NAIL. MHN NAIL WAS USED FOR A COMMINUTED FRACTURE FROM THE SURGICAL NECK OF THE HUMERUS TO THE CENTER OF THE GREATER TUBEROSITY. WHEN THE SURGEON INSERTED THE NAIL AFTER REDUCING AND TEMPORARILY FIXING THE FRACTURE, THE REDUCTION COLLAPSED. THE SURGEON CONFIRMED THAT THE FRACTURE WAS LATERAL AND ANTERIOR TO THE NAIL INSERTION SITE BUT CONTINUED WITH THE SURGERY. AFTER PROXIMAL-DISTAL LATERAL LOCKING, THE SURGEON CHECKED THE ENTIRE AREA AND FOUND THAT THE REDUCTION WAS STILL POOR AND THAT THE PROXIMAL SCREW WAS NOT ABLE TO FIX THE HUMERAL HEAD. REMOVAL OF THE PROXIMAL SCREW AND TRACTION IMPROVED REDUCTION. HOWEVER, WHEN THE SCREWS WERE INSERTED, THE REDUCTION WAS POOR AGAIN, SO THE SURGERY WAS COMPLETED BY REMOVING THE SCREWS AND POURING CEMENT THROUGH THE SCREW HOLES TOWARD THE FEMORAL HEAD. THE PATIENT'S HUMERAL HEAD HAS BEEN DISPLACED AND WILL BE REOPERATED ON (B)(6) 2023. THE NAIL AND OTHER IMPLANTS WILL BE REMOVED AND REPLACED WITH AN ARTIFICIAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 1 HOUR.

  Patient problems: Physical Asymmetry

  MAUDE report 17856787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103002. One submission often covers many models, so check the product and lot details in each record.

• Z-2060-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
• Z-2059-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu