SMARTSET GHV GENTAMICIN 40G

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> SMARTSET CEMENT THAT WAS DELIVERED TO THE HOSPITAL HAD THE VILE INSIDE THE BOX BROKEN. WHEN OPENING THE BOX OF CEMENT WE NOTICED THAT THE VILE WAS BROKEN THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT SMARTSET1.JPG, SMARTSET2.JPG. THE PHOTO INVESTIGATION REVEALED VISIBLE EVIDENCE OF LIQUID SPILLAGE INSIDE THE PACKAGING. IT IS REASONABLE TO CONCLUDE THAT THE AMBER VIAL WAS DAMAGED AND LED TO THE OBSERVED CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4513579], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE POTENTIAL CAUSE OF THE OBSERVED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES J&J MEDTECH ORTHOPAEDICS CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF J&J MEDTECH ORTHOPAEDICS CONTROL. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SMARTSET GHV GENTAMICIN 40G WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO TRANSPORT/STORAGE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4513579] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. CORRECTED INFORMATION: D4 (PRIMARY UDI #).

Description of Event or Problem

IT WAS REPORTED THAT THE SMARTSET CEMENT THAT WAS DELIVERED TO THE HOSPITAL HAD THE VILE INSIDE THE BOX BROKEN. WHEN OPENING THE BOX OF CEMENT, WE NOTICED THAT THE VILE WAS BROKEN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL MANUFACTURER NARRATIVE: D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN AND 510K ARE NOT AVAILABLE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- SMARTSET CEMENT THAT WAS DELIVERED TO THE HOSPITAL HAD THE VILE INSIDE THE BOX BROKEN. WHEN OPENING THE BOX OF CEMENT, WE NOTICED THAT THE VILE WAS BROKEN THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE AMBER VIAL IS DAMAGED, WITH VISIBLE EVIDENCE OF LIQUID SPILLAGE INSIDE THE PACKAGING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4513579], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE POTENTIAL CAUSE OF THE OBSERVED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES DEPUY SYNTHES CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE, THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF DEPUY SYNTHES CONTROL. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SMARTSET GHV GENTAMICIN 40G WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO TRANSPORT/STORAGE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT- A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4513579] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. ADDED: D9. CORRECTED: D3, G1, H3.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - SMARTSET CEMENT THAT WAS DELIVERED TO THE HOSPITAL HAD THE VILE INSIDE THE BOX BROKEN. WHEN OPENING THE BOX OF CEMENT, WE NOTICED THAT THE VILE WAS BROKEN. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT SMARTSET1.JPG, SMARTSET2.JPG. THE PHOTO INVESTIGATION REVEALED VISIBLE EVIDENCE OF LIQUID SPILLAGE INSIDE THE PACKAGING. IT IS REASONABLE TO CONCLUDE THAT THE AMBER VIAL WAS DAMAGED AND LED TO THE OBSERVED CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4513579], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE POTENTIAL CAUSE OF THE OBSERVED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. ONCE THE PRODUCT LEAVES J&J MEDTECH ORTHOPAEDICS CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS OR HUMAN INTERVENTION OR MANIPULATION THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE, THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF J&J MEDTECH ORTHOPAEDICS CONTROL. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SMARTSET GHV GENTAMICIN 40G WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO TRANSPORT/STORAGE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT - A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040 / 4513579] NUMBER, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: ADDED: H6. MEDICAL DEVICE PROBLEM CODE.