MalfunctionGDG
MICROBALL HOOK
Received Sep 25, 2024 · Event occurred Sep 19, 2024
Report MW5160111 · MDR key 20311838
Device
Generic name
Hook, Surgical, General & Plastic Surgery
Manufacturer
Aspen Surgical Products, Inc.Model number
80-1532Lot number
932750
Patient
67 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE HOOK, VERITY, NERVE, TI HANDLE, 2.0 MM BLUNT TIP, SS SHAFT, 7 1/4 IN, PART # 80-1532 MADE BY ASPEN SURGICAL BROKE OFF IN THE PATIENT DURING SPINAL SURGERY. IT IS THE 2ND HOOK TO BREAK WITHIN ONE WEEK. THE PIECE WAS RETRIEVED, SO THERE WAS NO PATIENT HARM, JUST A PRODUCT DEFECT.