MULTILOC 04.019.005SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982089571), received between Jan 27, 2026 and Jan 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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.

• MalfunctionJan 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY WITH MULTILOC FOR PROXIMAL HUMERUS FRACTURES. THE SURGEON SELECTED A 5MM END CAP, BUT IT BECAME STUCK MIDWAY THROUGH THE INSERTION PROCEDURE. THE SURGEON TRIED INSERTING THE END CAP AGAIN, THIS TIME PAYING ATTENTION TO ITS ORIENTATION, BUT STILL HAD DIFFICULTY COMPLETING IT. THE END CAP WAS REMOVED AND CHECKED, AND THE THREADS WERE FOUND TO BE UNDAMAGED WITH NO APPARENT DEFECTS. THE SURGEON MADE SURE THERE WERE NO OBSTRUCTIONS SUCH AS BONES, CLEANED THE END CAP, AND TRIED THE INSERTION AGAIN, BUT IT WAS UNSUCCESSFUL. THE SURGEON GAVE UP ON USING THE 5MM END CAP, AND A 2MM END CAP WAS INSERTED. HOWEVER, IT HAD BECOME EMBEDDED, AND THE SURGEON WAS CONCERNED THAT THE ANCHORING EFFECT COULD NOT BE ACHIEVED AND CHANGED IT TO A 10MM END CAP, BUT IT HAD PROTRUDED FROM THE JOINT SURFACE. ONE LAST ATTEMPT WAS MADE TO INSERT THE 5MM END CAP, AND IT WAS SUCCESSFUL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES' DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188920 ↗

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