TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR
Received Jan 9, 2019
Report 3004369035-2016-00007 · MDR key 8230403
Device
Generic name
Torque-shank, T7x80 Cannulated, Ao Connector
Manufacturer
I.t.s. GmbhModel number
54098-80Catalog number
54098-80
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) OF THE LAST THREE SHIPMENTS OF THE SCREWDRIVER SHANK 54098-80 AND THE RESP. SCREWS THAT WERE SEND TO GENERAL CARE WERE INSPECTED AND SHOWED NO DEVIATIONS. THE QUALITY FORMS MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED NO DEVIATION. THE MATERIAL WAS DETERMINED TO BE CONFORMING AND WAS USED AS IS PER PRODUCT DEVELOPMENT APPROVAL. WE HAVE TESTED THE SHANK WITH MULTIPLE HCS SCREWS FROM OUR STOCK AND THE SHANK ENGAGED SMOOTHLY IN THE TORQUE-PROFILE. NO DEVIATION RESP. NON-CONFORMANCE DETECTED.
Description of Event or Problem
IT WAS REPORTED THAT A HEADLESS COMPRESSION SCREW WAS MISMATCHING WITH THE TORQUE SHANK. THE INCIDENT DIDN'T HAPPEN IN SURGERY.