GPSIII 30 W/ACDA JP

Additional Manufacturer Narrative

(B)(4). LOT NUMBER ¿ THE LOT NUMBER CANNOT BE CONFIRMED, HOWEVER, IS LIKELY ONE OF 701805, 801851, 801854, 802306, OR 802556. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE UTILIZING A PLATELET CONCENTRATE SEPARATOR KIT, THE PLATELET RICH PLASMA (PRP) APPEARED PALER THAN NORMAL AND, WHEN ATTEMPTING TO INJECT, THE SURGEON WAS UNABLE TO USE PUSH THE SYRINGE PLUNGER. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. LOT NUMBER - 801851 OR 801854. PRODUCT WAS RETURNED AND EVALUATED. THE BLOOD IN THE SYRINGE IS OBSERVED TO BE PALER IN COLOR THAN EXPECTED. THE COMPLAINT IS CONFIRMED, HOWEVER, BASED ON THE WHETHER THE PATIENT HAD FASTED PRIOR TO THE PROCEDURE AND THE LIPID CONTENT (CREATES SLIGHT VARIATION IN PLASMA DENSITY) IN THE BLOOD THE RED CELL COUNT WILL VARY CAUSING DIFFERENCES IN THE APPEARANCE OF THE DEVICE OUTPUT THEREFORE, THE DEVICE OPERATED WITHIN SPECIFICATION REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. NO FAILURE WAS DETECTED AND THE DEVICE OPERATED WITHIN SPECIFICATION; THIS EVENT IS BEING REASSESSED AS NOT A MDR REPORTABLE EVENT AS THERE WAS NO DEVICE MALFUNCTION OR INJURY. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO ADDITIONAL EVENT INFORMATION RECEIVED.