MalfunctionHSH
NEXGEN ARTICULAR SURFACE INSERTER
Received Dec 9, 2010 · Event occurred Nov 8, 2010
Report 1822565-2010-01319 · MDR key 1950203
Device
Product problems
- Fracture
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE SURFACE INSERTER HAS FRACTURED.
Additional Manufacturer Narrative
THE FRACTURE LIKELY OCCURRED DUE TO THE INCORRECT MATERIAL BEING UTILIZED FOR THIS PRODUCTION LOT. THIS LOT HAS BEEN RECALLED, SEE 1822565-05/19/08-001R FOR ADDITIONAL DETAILS. DIMENSIONAL READING IS CONFORMING TO PRINT SPECIFICATION. MATERIAL HARDNESS IS NONCONFORMING. AS RETURNED, THE TIP OF THE ARTICULAR SURFACE INSERTER HAS FRACTURED AND WAS NOT RETURNED FOR REVIEW. THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 4 YEARS.
Remedial action
- Recall