CODMAN DISPOS PERFORATOR
Received May 29, 2026 · Event occurred May 13, 2026
Report 3014334038-2026-00037 · MDR key 25330499
Device
Generic name
Disposable Perforator
Manufacturer
Integra Lifesciences MansfieldCatalog number
261221
Lot number
7615945
Product problems
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A PHYSICIAN REPORTED A CODMAN PERFORATOR (ID 261221) HAD POOR MOVEMENT WHEN MAKING THE FIRST HOLE. WHEN INSPECTING THE DEVICE OUTSIDE THE SURGICAL FIELD, THE OUTER PLASTIC SLEEVE CAME OFF, AND THE INNER DRILL CAME OUT. THERE WAS NO REMAINING PART OF THE PRODUCT IN THE PATIENT¿S BODY. THEREFORE, STAINLESS STEEL INSTRUMENTS, SUCH AS A CURETTE, WERE USED TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED BY APPROXIMATELY 30 TO 60 MINUTES DUE TO PERFORATOR FAILURE. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE DRILL IS ELECTRIC OR PNEUMATIC, IF THE PERFORATOR CLICKS IN PLACE IN THE DRILL, AND IF THE RECOMMENDED SPRING TESTS BEING PERFORMED BETWEEN EACH BURR HOLE.
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.