SALVATION
Received Sep 15, 2017 · Event occurred Aug 18, 2017
Report 1043534-2017-00097 · MDR key 6868049
Device
Generic name
Bit, Surgical
Manufacturer
Wright Medical Technology, Inc.Model number
SB080045Lot number
NI
Product problems
- Break
- Break
Patient
Not reported
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE. ALLEGEDLY, WHILE DRILLING FOR THE 5.0 BOLT THE 4.5/3.2 TAPERED DRILL BROKE INSIDE THE METATARSAL. THE SURGEON WAS ABLE TO GET THE BROKEN DRILL BIT OUT BY CREATING A BIGGER DRILL CANAL BUT NEEDED TO USE A LESS THAN OPTIMAL SIZED 6.5 BOLT. IMPACT TO PATIENT WAS LESS THAN OPTIMAL SIZED BOLTS FOR THE LATERAL COLUMNS. THE 6.5 BOLT USED INSTEAD OF THE 5.0 BOLT FRACTURED THE METATARSAL.