SMARTSET GHV GENTAMICIN 40G

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. H11 ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DMF# - (B)(4), TRADE NAME ¿ GENTAMICIN SULPHATE, ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE, DOSAGE FORM - POWDER, STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT CEMENT IS FAULTY AND TAKES LONGER TIME TO SET. THERE WAS A 10 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: CEMENT IS FAULTY AND TAKES LONGER TIME TO SET. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040/ 4600739], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. A RETAINED SAMPLE TEST WAS PERFORMED FOR THIS PRODUCT AND LOT COMBINATION. THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET THE APPROPRIATE CONTROL SPECIFICATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3095040/4600739], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES HAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D10. CORRECTED: B3. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.