MalfunctionFMP
SHOULDER TOWER SUSPENSION SYSTEM
Received Dec 22, 2016 · Event occurred Nov 22, 2016
Report 1221538-2016-00003 · MDR key 6199277
Device
Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AWAITING THE RETURN OF THE DEVICE FOR ROOT CAUSE EVALUATION, REMEDIATION DETERMINATION AND IMPLEMENTATION. A FOLLOW-UP MDR WILL BE FILED.
Description of Event or Problem
FAIRLY EARLY IN THE CASE. PRIOR TO ANCHOR PLACEMENT. THEY TRIED TO ADJUST INTERNAL/EXTERNAL ROTATION SEVERAL TIMES. THE RIVETED SCREW ON THE BOOM FELL OUT AND INTO THE STERILE FIELD. THERE WAS NO KNOWN INJURY/ADVERSE EVENT TO THE PATIENT DUE TO THIS INCIDENT.