CODMAN DISPOS PERFORATOR
Received May 12, 2008
Report 1226348-2008-00120 · MDR key 1044598
Device
Generic name
Drills, Burrs, Trephines & Acc.
Manufacturer
Codman & Shurtleff, Inc.Model number
NACatalog number
26-1221
Lot number
AA960
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
CUSTOMER REPORTS THAT: "THIS BURR TORE DURA WITH TWO BURR HOLES. THIRD BURR HOLE DID NOT GO ALL WAY THRU - HAD TO GET HUDSON DRILL TO FINISH IT".
Additional Manufacturer Narrative
HISTORICALLY FOR COMPLAINTS OF THIS NATURE, THE RETURNED PERFORATORS HAVE BEEN VISUALLY INSPECTED AS RECEIVED, DISASSEMBLED AND CLEANED, AND THEN VISUALLY AND DIMENSIONALLY INSPECTED. NO DISCREPANCIES HAVE BEEN FOUND. THE PERFORATORS HAVE BEEN REASSEMBLED AND WERE FUNCTIONALLY TESTED FOR CUTTING AND DRILLING. THEY'VE BEEN FOUND TO MEET SPECIFICATION REQUIREMENTS. THE REPORTED CONDITION COULD NOT BE DUPLICATED. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE FOUND NO DISCREPANCIES. THE COMPLAINTS HAVE NOT BEEN CONFIRMED. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.