PERIOTOME HATCHET DE
Received Sep 8, 2015 · Event occurred Aug 7, 2015
Report 2523190-2015-00069 · MDR key 5060731
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ON 9/16/15 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - PERIOTOME HATCHET IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKING. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE COMPLAINT REPORT HAS BEEN CONFIRMED, THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP MATERIAL DEFICIENCY.
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS THEY ONLY HAD DEVICE FOR 2-3 MONTHS AND INSTRUMENT BROKE IN PATIENT'S MOUTH. (B)(6) 2015 DOCTOR REPORTS HE WAS EXTRACTING A MOLAR WHEN THE TIP BROKE OFF THE DEVICE IN THE PATIENTS MOUTH. PIECE REMOVED WITH NO HARM TO THE PATIENT.