MULTILOC 04.016.039SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982089212), received between Mar 18, 2022 and Sep 22, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 5 most recent of 5 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 50862692 ↗
• MalfunctionApr 11, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHEN THE 9.5MM RIGHT SIDE MULTILOC PROX HUMERUS NAIL PACKAGE WAS OPENED IT WAS FOUND THAT A LEFT SIDE NAIL WAS PACKAGED IN THE BOX BUT HAD A RIGHT SIDE LABEL. THE PATIENT WAS NOT AFFECTED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851719 ↗
• InjuryMar 26, 2024Adverse 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 MULTI LOCKING FIXATION FOR HUMERUS SURGICAL NECK FRACTURE. THE DISTAL LOCKING SCREW LOOSENED, AND THE FRACTURE SITE BEGAN TO OPEN. IT WAS PLANNED TO REMOVE THE NAIL AND REPLACE WITH A REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9.5MM TI MULTILOC PROX HUMERAL NAIL/LT/CANN/160MM-STER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18980444 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT AN ORIF SURGERY WITH MHN IMPLANTS FOR A FRACTURE OF THE LEFT PROXIMAL HUMERUS. THE SURGEON USED A DRILL SLEEVE FOR THE DISTAL WHEN HE DRILLED THE PROXIMAL AP HOLE. GAPS BETWEEN THE DRILL SLEEVE AND THE HOLE CAUSED THE DRILL HOLE TO SHIFT AND THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DRILLED MANUALLY AT THE SURGEON¿S DISCRETION AND SUCCEEDED IN MAKING A HOLE. THE SCREW WAS INSERTED SUCCESSFULLY. WHEN THE SURGEON WAS INSERTING DISTAL LOCKING SCREWS, DRILLING WAS DONE SMOOTHLY FOR ONE OF THE LOCKING SCREWS, AND THE DRILL BIT WAS LEFT FOR FIXATION. HOWEVER, ANOTHER DRILL BIT ALSO INTERFERED WITH THE NAIL WHEN IT WAS USED TO DRILL A HOLE FOR A 2ND DISTAL LOCKING SCREW. THE SURGEON DRILLED MANUALLY FOR THE HOLE AND INSERTED THE DISTAL LOCKING SCREW SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FRAGMENTS WERE LEFT IN THE PATIENT, THE SURGEON CONFIRMED THIS VIA X-RAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 9.5MM TI MULTILOC PROX HUMERAL NAIL/LT/CANN/160MM-STER. THIS IS RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687586 ↗
• MalfunctionMar 18, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE POST OP INSPECTION OF SCREW RACK IS PEELING, ALONG WITH NON LOCKING PLATE SET CUSHIONS. MULTILOCK NAIL PACKAGING WAS ALSO TORN DURING TRANSPORT. PATIENTS INVOLVEMENT IS THERE THIS COMPLAINT INVOLVES (1) DEVICE 9.5 TI MULTILOC PRX HUM NL/LT/CANN/160-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804466 ↗

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-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
• 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