TALON DISTALFIX PROXIMAL FEMORAL NAIL
Received Jan 13, 2017 · Event occurred Dec 7, 2016
Report 1064129-2017-00001 · MDR key 6248900
Device
Generic name
Intramedullary Fixation Rod
Manufacturer
Orthopedic Designs North America, Inc.Catalog number
SLN-125-40L
Lot number
CT12L059
Product problems
- Break
- Break
Patient
66 YR
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
REVIEW OF DEVICE HISTORY RECORDS INDICATE THE PRODUCT MET ALL QUALITY INSPECTIONS AND WAS RELEASED WITHIN SPECIFICATIONS. POTENTIAL NAIL BREAKAGE HAD BEEN CONSIDERED IN THE RISK MANAGEMENT FILE. THE SURGICAL TECHNIQUE GUIDE AND PRODUCT INSERT STATE THAT THIS TYPE OF EVENT CAN OCCUR. AS THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION THE ROOT CAUSE OF THE BROKEN NAIL IS UNDETERMINED.
Description of Event or Problem
ON (B)(6) 2016 IT WAS REPORTED THAT THERE WAS A BROKEN NAIL THAT HAD BEEN REMOVED THE PREVIOUS WEEK. IT WAS ALSO REPORTED THAT THERE WERE MULTIPLE IMPLANTS PRESENT AT THE TIME OF THE REMOVAL AND THAT THE CAUSE OF THE NAIL BREAKAGE WAS UNKNOWN.