FP SHROUD VER 2 REWORKED

Description of Event or Problem

IT WAS REPORTED THAT SOME PAINT FLAKED OFF AND FELL INTO THE PATIENT. LATER IT WAS CLARIFIED BY A NURSE THAT THE PEELING PAINT FELL ON THE STERILE DRAPE AT THE FOOT OF THE PATIENT.

Additional Manufacturer Narrative

IN ADDITION TO THE PATIENT IDENTIFIER INITIALS, A PATIENT ID# ((B) (6)) WAS ALSO COMMUNICATED TO STRYKER FROM (B) (6), AGE, WEIGHT, AND SEX OF THE PATIENT WERE NOT COMMUNICATED TO STRYKER. CONCLUSION CODE DESCRIPTION: MALFUNCTION DID OCCUR; IT DID NOT LEAD TO AN ADVERSE EVENT. RECURRENCE COULD POTENTIALLY LEAD TO AN ADVERSE EVENT. CAPA (B) (4) ADDRESSES THESE CORRECTIVE AND PREVENTATIVE ACTIONS TO THIS ISSUE. ROOT CAUSE: FIRST 300 SHROUDS DELIVERED BY SUPPLIER WERE NOT THE EXACT MATCHING COLOR DUE TO A VARIATION IN THE MOLDING PROCESS. THE SHROUDS WERE SUBSEQUENTLY REWORKED. THE PATIENT USED DID NOT ADHERE TO THE SHROUD VERY WELL AND ULTIMATELY CHIPPED OFF.