HAND-REAMER F/MEDULL-CANAL Ø6
Received Apr 27, 2026 · Event occurred Apr 10, 2026
Report 8030965-2026-03870 · MDR key 25008042
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE SURGERY, WHILE THE ORTHOPEDIC SURGEON WAS REAMING THE MEDULLARY CANAL OF THE FEMUR, THE REAMER BECAME STUCK. THE DOCTOR ATTEMPTED TO WITHDRAW IT USING ROTATIONAL MOVEMENTS BUT WAS UNSUCCESSFUL; HE ALSO TRIED TO EXTRACT IT BY APPLYING GENTLE TAPS, AND IT WAS AT THAT MOMENT THAT THE HANDLE WAS BROKEN INTO T. THE REAMER WAS FINALLY SUCCESSFULLY EXTRACTED, AND THE SURGERY PROCEEDED WITHOUT FURTHER COMPLICATIONS.