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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE HOSPITAL HAD A VIAL OF CEMENT MONOMER WITH A HAIR WRAPPED ROUND IT. THERE WAS NO IMPACT TO PATIENT AS ITEM WAS NOT USED. THERE WAS A 5 MINUTE DELAY TO SET UP WHILST ANOTHER MONOMER WAS COLLECTED AND OPENED. THIS WAS DONE BEFORE SURGERY WAS STARTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: HOSPITAL HAVE CONTACTED ME THIS MORNING TO ADVISE THAT THEY HAVE HAD A VIAL OF CEMENT MONOMER WITH A HAIR WRAPPED ROUND IT. THE INCIDENT DATE WAS (B)(6) 2025 NO IMPACT TO PATIENT AS ITEM NOT USED. 5 MIN DELAY TO SET UP WHILST ANOTHER MONOMER WAS COLLECTED AND OPENED. THIS WAS DONE BEFORE SURGERY WAS STARTED. THE PRODUCT IS NOT AVAILABLE FOR RETURN. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPH OF THE COMPLAINT UNIT WAS FORWARDED TO THE MANUFACTURING SITE J&J MEDTECH BLACKPOOL, FOR A MANUFACTURING INVESTIGATION THE PHOTO INVESTIGATION REVEALED THAT THE AMPOULE BLISTER PACKAGING WAS OPEN AND HAS A HAIR WRAPPED ROUND IT. 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 INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH ORTHOPAEDICS QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A NR WAS RAISED TO ADDRESS CURRENT COMPLAINT CONDITION.