NA

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A HAIR IN THE SEALED PACKAGING OF THE DEVICE. THE ISSUE WAS NOTICED IN INVENTORY. THE DEVICE DID NOT COME IN CONTACT WITH A PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

Additional Manufacturer Narrative

THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. INSPECTION OF THE RETURNED DEVICE CONFIRMED THE PACKAGING WAS SEALED AND A FOREIGN MATERIAL WAS PRESENT. BY FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY, THE CONTAMINANT PRESENT IN THE PACKAGING IS CONSISTENT WITH A REFERENCE SPECTRUM AVAILABLE FOR HUMAN HAIR (PROTEINACEOUS AMIDE). THE MOST LIKELY ROOT CAUSE IS A PROCESSING ERROR PRIOR TO DISTRIBUTION FROM SSS. ACTION IS BEING TAKEN TO ASSESS THE ISSUE. THE REPORTED EVENT WITH CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.