DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM
Received May 15, 2026 · Event occurred Apr 28, 2026
Report 8030965-2026-04612 · MDR key 25182822
Device
Product problems
- Material Deformation
Patient
Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED UPON INSPECTING THE MEASURING DEVICE DURING SURGERY, WE IDENTIFIED THAT ITS TIP WAS MISALIGNED. THE SPECIALIST REQUESTED THAT THE SALES DEPARTMENT INFORM HIM ABOUT MISSING ITEMS WHEN VALIDATING MATERIALS BEFORE THEY ARRIVED AT THE INSTITUTION, SINCE THE 10MM L315 NAIL, THE ONE REQUIRED FOR THE PROCEDURE, WAS NOT AVAILABLE. A 11MM DIAMETER NAIL WAS USED AND FUNCTIONED CORRECTLY. ADDITIONALLY, THE SPECIALIST ALSO MENTIONED THAT THIS WAS HIS SECOND TIME OPERATING WITH J&J TNA SCREWS, AND DURING THE PROCEDURE, HE DECIDED TO PLACE THE PROXIMAL DYNAMIC SCREW, WHICH ENDED UP OVER THE FRACTURE LINE. BOTH THE RESIDENT AND I INFORMED HIM THAT THE SCREW WAS VISIBLE OVER THE FRACTURE LINE, BUT HE DECIDED TO LEAVE IT AS IS.
Additional Manufacturer Narrative
PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.