MalfunctionHTW
DARCO HEADED DRILL BIT 6.5MM
Received Jun 25, 2012
Report 8043862-2012-00008 · MDR key 2630928
Device
Generic name
Drill
Manufacturer
Aap Implantate AgModel number
IW706522Catalog number
IW706522
Lot number
W002
Product problems
- Break
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
ALLEGEDLY THE DRILL BITS FAILED/BROKE.
Additional Manufacturer Narrative
THE BROKEN DRILL HAS BEEN CHECKED BY THE SUPPLIER IN DETAIL. NO DEVIATION HAS BEEN IDENTIFIED FROM THE SPECIFICATION. THE SUPPLIER ASSUMES THAT THE DRILL COLLIDED WITH SOMETHING MADE OF METAL DURING SURGERY WHICH COULD BE THE DRILL GUIDE OR ANOTHER IMPLANT THAT HAS BEEN IMPLANTED BEFORE. UNFORTUNATELY THE DISTRIBUTOR (B)(4) DID NOT PROVIDE ANY INFO.