AIR HOSE 5.0M SCHRADER/AESCULAP SMALL

Description of Event or Problem

THE MALFUNCTION IS RECORDED IN AAG REFERENCE100031669 ((B)(4)). INVOLVED COMPONENTS: (B)(4) - GB757R - HI-LINE XS ANGLED HANDPIECE II - LOT 4504569732. (B)(4) - GB508R - ECCOS FIXATION F/GA643 - LOT UNKNOWN. (B)(4) - S75556 - PNEUMATIC MOTOR - LOT 4503716806.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION/CORRECTION: D10 - LOTS UPDATED FOR ALL INVOLVED COMPONENTS. H6 - CODES. INVESTIGATION RESULTS: VISUAL INVESTIGATION: OPTICALLY, THE BURST OF THE OUTER HOSE CAN BE CONFIRMED. FURTHERMORE THERE ARE SIGNS OF USAGE. THE INVESTIGATION HAS BEEN CARRIED-OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). DURING THE INVESTIGATION, THE BURST OF THE OUTER AIR HOSE COULD BE CONFIRMED. FURTHERMORE THE TUBE CONNECTION OF THE INNER HOSE HAS LOOSENED. THE MAINTENANCE DATE WHICH CAN BE FOUND ON THE PRODUCT INDICATES A DUE DATE OF 2021-12. THIS INDICATES THAT A MAINTENANCE WAS OVERDUE BY THE TIME OF THE INCIDENT. AN INFORMATION REGARDING THE MAINTENANCE OF THE DEVICE CAN BE FOUND WITHIN THE CORRESPONDING IFU TA014481 2020-03. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 4(5) X PROBABILITY 1(5) OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS THE ROOT CAUSE IS MOST PROBABLY MAINTENANCE-RELATED. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

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 GA506R - AIR HOSE 5.0M SCHRADER/AESCULAP SMALL ACCORDING TO THE COMPLAINANT, THE PRODUCT "BURST". THIS OCCURRED AFTER CUTTING BONE 2-3 TIMES, AND PLACING THE PRODUCT ON THE INSTRUMENT TABLE. THERE WAS TEMPORARY IMPAIRMENT OF THE STAFF (HEARING). THE ADVERSE EVENT / MALFUNCTION IS RECORDED IN AAG REFERENCE (B)(4). INVOLVED COMPONENTS: (B)(4) - GB757R/HI-LINE XS ANGLED HANDPIECE II - LOT 4504569732. (B)(4) - GB508/ECCOS FIXATION F/GA643 - LOT UNKNOWN. (B)(4) - S75556/PNEUMATIC MOTOR - LOT 4503716806.