MalfunctionGFJ
ORTHOPEDIC 2POUND/1POUND MALLET
Received Oct 21, 2013 · Event occurred Sep 30, 2013
Report 3005236665-2013-00008 · MDR key 3537202
Device
Generic name
Orthopedic Mallet
Catalog number
KM46666
Lot number
B0
Product problems
- Material Deformation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE COMPLAINT WAS REPORTED AS: COMPLAINT ALLEGES: "AFTER FOUR MONTHS THE CONDITION AND SHAPE OF THE MALLETS HAVE DEFORMED, AND BITTED AROUND THE EDGES OF THE MALLET HEADS. CONCERNED CUSTOMER MENTIONED THAT SOME BITS OF THE MALLETS MAY HAVE FALLEN INSIDE THE PATIENT HOWEVER THERE HAS BEEN NO REPORTS OF THIS". THERE WAS NO MEDICAL INTERVENTION. PATIENT CONDITION LISTED AS FINE.
Additional Manufacturer Narrative
DEVICE SAMPLE HAS BEEN RECEIVED BY MANUFACTURER, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.