RIA 2 BONE HARVESTING KIT 520MM STERILE

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: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED DURING A TUMOR RESECTION PROCEDURE AN ISSUE OCCURRED WITH THE REAMER. THE REAMER ITSELF HAS BECOME STUCK IN THE JOINT, WHICH PREVENTED FROM PROPERLY REAMING AS INTENDED. ADDITIONALLY, THE YELLOW PIECE ALONG WITH THE JOINT IS ALSO JAMMED AND CANNOT BE MOVED. USE OF THE RIA WITH RESERVOIR. ASSEMBLY AND USE IN ACCORDANCE WITH THE MANUFACTURER'S STANDARDS AND DESCRIPTION. AFTER USE, IT WAS OBSERVED THAT THE YELLOW PLASTIC PART HAD BROKEN AND SHATTERED INTO MULTIPLE FRAGMENTS, WHICH BLOCKED THE REUSABLE PART OF THE RIA REAMING SHAFT. THERE IS RISK OF A FOREIGN BODY LEFT IN THE PATIENT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE. THERE WAS NO PATIENT CONSEQUENCE.