COFLEX INTERLAMINAR TECHNOLOGY

Additional Manufacturer Narrative

VISUAL AND FUNCTIONAL ASSESSMENTS COULD NOT BE PERFORMED DUE TO THE COMPLAINT INSTRUMENT NOT BEING RETURNED FOR ASSESSMENT. A DHR REVIEW COULD NOT BE PERFORMED DUE TO THE LOT NUMBER OF THE COMPLAINT INSTRUMENT NOT BEING AVAILABLE. THE AGE OF THE COMPLAINT INSTRUMENT COULD NOT BE IDENTIFIED. THE HEAD OF THE SYSTEM MALLET IS SECURED INTO THE HANDLE WITH AN EPOXY GLUE. IT MAY BE POSSIBLE THAT REPEATED USE AND EXPOSURE TO STERILIZATION CYCLES MAY HAVE CONTRIBUTED TO THE GLUE NOT MAINTAINING ADHESION AS INTENDED. REPEATED IMPACTS TO THE MALLET AS WELL AS EXPOSURE TO STERILIZATION CYCLES MAY HAVE CONTRIBUTED TO THE REPORTED INSTRUMENT MALFUNCTION. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE RELIABLY DETERMINED. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS INSTRUMENT FOR COMPLAINTS FROM THE FIELD.

Description of Event or Problem

THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON 6/27/2023. IT WAS REPORTED THAT THE HEAD OF A SYSTEM MALLET FRACTURED FROM THE HANDLE OF AN INSTRUMENT WHILE BEING USED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT, AN ALTERNATE AVAILABLE MALLET FROM THE SURGICAL FACILITY WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. EMAIL INQUIRIES WERE SENT TO THE COMPLAINANT FOR ADDITIONAL COMPLAINT INCIDENT INFORMATION AND RETURN OF THE COMPLAINT INSTRUMENT, WHICH WERE UNSUCCESSFUL. AN RMA NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH AS OF 7/26/2023 HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.