MALLET
Received May 15, 2013 · Event occurred Apr 16, 2013
Report 0001825034-2013-01524 · MDR key 3114390
Device
Generic name
Orthopedic Manual Surgical Instrument
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
UNKNOWN MALLET
Lot number
UNKNOWN
Product problems
- Difficult to Remove
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. A SUBSEQUENT REVISION WAS PERFORMED ON (B)(6) 2013 DUE TO UNKNOWN REASONS. WHILE THE SURGEON WAS ATTEMPTING TO REMOVE THE HEAD WITH A MALLET, THE HEAD BECAME COLD WELDED TO THE STEM RESULTING IN A DELAY OF OVER TWO HOURS.
Additional Manufacturer Narrative
CURRENT INFORMATION INDICATES THE USE OF INCORRECT INSTRUMENTATION CAUSED THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THERE ARE WARNINGS IN THE ASSOCIATED PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT STATES, "SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01508 & 01524).