Description of Event or Problem · 0
ON 12/05/2024, STRYKER REPORTED (PR ID (B)(6)) TO INNOMED, INC. THAT STRYKER CATALOG #4230-01NM WAS MISPLACED DURING SURGERY BY THE SURGICAL TEAM. THE SURGICAL TEAM IDENTIFIED THE ISSUE VIA IMAGING AFTER THE PROCEDURE. THE PATIENT REQUIRED A SECOND SURGERY TO REMOVE THE PATELLA PLATE. AT THE TIME OF THE REPORT, NEITHER STRYKER NOR THE END USER HAD REPORTED THE EVENT AS MANDATED BY THE FDA MDR REQUIREMENTS. INNOMED, INC. REQUESTED THAT THE DEVICE BE RETURNED TO CONFIRM IT TO BE AN INNOMED DEVICE HAD PERFORM A PROPER EVALUATION. AFTER MULTIPLE REQUESTS BY INNOMED, INC., STRYKER REPORTED TO INNOMED, INC., THAT THEY COULD NOT OBTAIN THE DEVICE OR ANY ADD'L INFO FROM THE REPORTER. BASED ON THE LIMITED INFO PROVIDED, THERE IS NO INDICATION THAT THE DEVICE FAILED, AND INNOMED BELIEVES THE SURGICAL TEAM FAILED TO ACCOUNT FOR THE DEVICE BEFORE COMPLETING THE PROCEDURE, CAUSING ADD'L SURGERY TO RECOVER THE DEVICE. REF: INNOMED, INC. CUSTOMER FEEDBACK (B)(4) FOR DETAILS.