MEAD MALLET W/NYLON CAPS
Received Oct 12, 2011
Report 2523190-2011-00074 · MDR key 2404344
Device
Product problems
- Break
Patient
58 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem
CUSTOMER MEDWATCH # (B)(4) - EVENT DESCRIPTION: DURING ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION), THE SURGEON WAS CHECKING THE SIZE OF SPACER NEEDED WITH TRIAL AND HANDLE. THE NYLON FACE OF THE MALLET BROKE OVER THE SURGICAL FIELD. ALL PIECES OF THE NYLON FACE WERE RETRIEVED. ON (B)(6) 2011, CUSTOMER REPORTS NO PT HARM VIA PHONE. THE ORIGINAL INTENDED PROCEDURE: C2-C3, C3-C4 ANTERIOR CERVICAL DISCECTOMY, OSTEOPHYTECTOMY AND INSTRUMENTATION AND FUSION WITH TITANIUM GRAFTS. POSTERIOR CERVICAL LAMINECTOMY C2-C4 UNDER FLUOROSCOPIC GUIDANCE. DEVICE USAGE PROBLEM: (EG. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).