CS SOLID HDL SERR W/RULE
Received Feb 11, 2016
Report 2523190-2016-00012 · MDR key 5432201
Device
Generic name
M52 - Hygiene / Periodontal
Manufacturer
Integra York, Pa Inc.Catalog number
67-688
Lot number
UNKNOWN
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
2//22/16 INTEGRA INVESTIGATION COMPLETED. METHOD : FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS : FAILURE ANALYSIS - A MIRROR HANDLE WAS RETURNED IN USED CONDITION, SHOWING WEAR AND AN ORANGE TAPE MARKING, STAINING AND MIRROR DETACHED (BROKEN). UPON EVALUATING THE INSTRUMENT, IT IS NOTICED THAT THE MIRROR HAS BROKEN OFF OF THE HANDLE. WITHOUT KNOWING HOW THE INSTRUMENT WAS HANDLED AND MAINTAINED DURING USE, THE CAUSE IS UNDETERMINED. THE INSTRUMENT APPEARS TO BE USED AND OLD. THE COMPLAINT REPORT IS CONFIRMED; DAMAGED WORN. DEVICE HISTORY EVALUATION - DHR REVIEW WAS COMPLETED WITH ALL HISTORY AVAILABLE. 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 ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR 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 REPORTS THIS DETACHABLE HANDLE AS BROKEN. ON (B)(6) 2016 CUSTOMER REPORTS DOCTOR WAS DOING A ROUTINE DENTAL EXAM USING THE MIRROR TO RETRACT THE CHEEK WHEN THE MIRROR (DEXITER USA #5 MIRROR) CAME OFF THE UNIVERSAL HANDLE, NO HARM DONE. NO FURTHER INFORMATION AVAILABLE.