inforMED
MalfunctionGFJ

ORTHOPEDIC 2POUND/1POUND MALLET

Received Oct 28, 2013 · Event occurred Sep 30, 2013

Report 3005236665-2013-00010 · MDR key 3532515

Device

Generic name

Orthopedic Mallet

Catalog number

KM46666

Product problems

  • Detachment Of Device Component

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE COMPLAINT WAS REPORTED AS: COMPLAINT ALLEGES: DURING A TOTAL JOINT PROCEDURE, THE HEAD FLEW OFF THE SHAFT OF THE INSTRUMENT. THERE WAS NO MEDICAL INTERVENTION. NO PT OR MEDICAL STAFF INJURY REPORTED.

Additional Manufacturer Narrative

DEVICE SAMPLE HAS NOT BEEN REC'D BY MFR IN TIME FOR THIS REPORT.