MILTEX MALLET 11 16OZ
Received Nov 16, 2015
Report 2523190-2015-00121 · MDR key 5226730
Device
Product problems
- Break
- Device Dislodged or Dislocated
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ON 12/14/2015 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS: A MALLET RETURNED IN USED CONDITION, WITH (B)(6) 2015 ETCHED INTO HANDLE. IT IS NOTICED THERE ARE SCRATCHES AND DENTS OF VARYING DEGREES ON THE MALLET. EVALUATION OF THE MALLET SHOWS THAT THE HEAD IS SECURELY ATTACHED TO THE HANDLE AND THE WELD IS STILL INTACT. . DUE TO THE WEAR, TEAR OF THE MALLET AND UNABLE TO CONFIRM REPORT. THE COMPLAINT IS UNCONFIRMED; UNABLE TO CONFIRM REPORT. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY. VARIANCE AUTHORIZATION / DEVIATION HISTORY: THERE IS NO APPLICABLE VARIANCE AUTHORIZATION / DEVIATION HISTORY ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: THERE IS NO APPLICABLE CORRECTIVE ACTION PREVENTIVE ACTION HISTORY. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE COMPLAINT IS UNCONFIRMED; UNABLE TO CONFIRM REPORT.
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS DEVICE IS DEFECTIVE. ON (B)(6) 2015 CUSTOMER REPORTS THE HEAD OF MALLET BROKE OFF IN USE. NO ONE HURT AT THIS TIME BUT FEAR THAT COULD HAPPEN.