DEPUY CMW 2G 20G

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. ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 AN EMPTY AMPOULE WITH A MISSING GLASS NOTCH WAS FOUND WHEN THE BOX WAS OPENED. THE GLASS AMPOULE WAS INTEGER BUT WITHOUT CEMENT. THERE WAS A HOLE PRESENT ON THE SURFACE. THE CEMENT WAS NOT PRESENT IN THE BOTTOM OF THE BOW (NO LEAK). A NEW CEMENT BOX WAS OPENED TO USE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, ¿AT THE TIME OF USING THE CEMENT, OPENING THE BOX THE IDE FOUND AN EMPTY AMPOULE WITH A MISSING GLASS NOTCH. THE CEMENT DID NOT POUR INTO THE PACKAGING, AND THE BULB WAS NOT BROKEN INTO PIECES, SUGGESTING A MANUFACTURING DAFAUT. A NEW CEMENT BOX WAS OPENED, COMPLIANT THIS TIME.¿ PRODUCT DESCRIPTION:- DEPUY CMW 2G 20G PRODUCT CODE:- 3325020 LOT NO:- 4592283 QUANTITY OF MANUFACTURED: - 1390 DATE OF MANUFACTURING: - 18-SEPTEMBER-2024 EXPIRY DATE: - 31-AUGUST-2027. THERE WAS ONE NC FOR THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH COULD CONTRIBUTE TO THE COMPLAINT EVENT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATIONS. A REVIEW OF THE DHR CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED. 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 PRODUCT DESCRIPTION: - DEPUY CMW 2G 20G PRODUCT CODE:- 3325020 LOT NO:- 4592283 QUANTITY OF MANUFACTURED:- (B)(4) DATE OF MANUFACTURING:- 18-SEPTEMBER-2024 EXPIRY DATE:- 31-AUGUST-2027. DEVICE HISTORY REVIEW THERE WERE ONE NC FOR THIS LOT. ON REVIEW OF THE APPLICABLE NCS NONE HAVE BEEN IDENTIFIED WHICH COULD CONTRIBUTE TO THE COMPLAINT EVENT. ALL QC AND MICROBIOLOGY TESTING MET SPECIFICATIONS. A REVIEW OF THE DHR CONFIRMED THAT THERE WERE NO PROCESS ISSUES DOCUMENTED THAT COULD CONTRIBUTE TO THE EVENT DESCRIBED.