ACCULAN SAGITTAL SAW ATTACHMENT

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT GB660R - ACCULAN SAGITTAL SAW ATTACHMENT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SAW HEAD DETACHED AND INTERNAL PARTS (INCLUDING THE BALL BEARINGS AND THE SPRING) FELL INTO THE SURGICAL FIELD. THIS OCCURRED DURING THE CUTTING PHASE OF THE HUMERAL HEAD. REMOVAL OF THE SAW AND ALL ITS DETACHED PARTS, AND REPLACEMENT OF THE EQUIPMENT WAS PERFORMED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS NOT MADE AVAILABLE FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE BATCH NUMBER WAS NOT PROVIDED. EVEN AFTER MEANINGFUL ATTEMPTS, NO FURTHER INFORMATION WAS RECEIVED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.