2.5 MM FEMALE HEX SCREW 25 MM LENGTH

Additional Manufacturer Narrative

(B)(4). (B)(6). 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, WHEN THE NURSE PEELED THE OUTER TYVEK, THE INNER STERILE TYVEK WAS ALSO PEELED, BECAUSE IT ALREADY HAD ADHERED TO THE OUTER TYVEK. THE PRODUCTS WITHIN THE INNER STERILE TRAY FLEW OUT AND FELL ON THE FLOOR. OTHER PINS WERE USED TO COMPLETE THE PROCEDURE.

Additional Manufacturer Narrative

THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH VISUAL INSPECTION. THE RETURNED PACKAGING IDENTIFIED THAT THE INNER TYVEK PACKAGING WAS SEALED TO THE OUTER TYVEK CAVITY SEAL, CAUSING THE INNER TYVEK TO RELEASE WHEN THE OUTER TYVEK LID WAS PEELED OFF. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. THE LID OF THE INNER CAVITY WAS NOT SEALED PROPERLY AND THIS NON-CONFORMANCE WAS NOT CAUGHT DURING VISUAL INSPECTION OF THE SEALED PRODUCT, DESPITE THE PACKAGING AND INSPECTION PROCEDURES IN PLACE TO PREVENT THIS ISSUE. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS CONSIDERED TO BE A MANUFACTURING DEFICIENCY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.