CORE DECOMPRESSION DISP HIP

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR RETURN TO MANUFACTURER; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. AN EVALUATION OF THE DEVICE WILL NOT BE NECESSARY, AS THE DEVICE PROBLEM IS ALREADY KNOWN. DECISION WAS MADE TO RECALL BASED ON AN INVESTIGATION WHICH IDENTIFIED THAT TROCAR AND PLUNGER ASSEMBLIES WERE MISSING FROM THE PACKAGE CONTAINING THE PERFUSE DECOMPRESSION INSTRUMENT. THIS COULD RESULT IN A DELAY TO A SURGICAL PROCEDURE WHILE AN ALTERNATIVE INSTRUMENT IS LOCATED.

Additional Manufacturer Narrative

DEVICE CODE - FMF. DEVICE INFO - QUANTITY 2. DEVICE AVAILABILITY - THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN, BUT HAS NOT YET BEEN RECEIVED. THIS DEVICE HAS NOT YET RETURNED; HOWEVER, AN EVALUATION WAS COMPLETED ON ANOTHER DEVICE OF THE SAME LOT. CONCLUSION: DEVICE OUT OF SPECIFICATION IN A MANNER THAT RELATES TO THE EVENT. EVALUATION OF ANOTHER DEVICE FROM THE SAME LOT REVEALED EVIDENCE OF PRODUCT NON-CONFORMANCE. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED TO ADDRESS THE REPORTED ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A CORE DECOMPRESSION PROCEDURE FOR AVASCULAR NECROSIS ON (B)(6) 2016. DURING THE PROCEDURE, THE SHARP AND BLUNT TROCARS WERE MISSING IN THE PACKAGING. ANOTHER CORE DECOMPRESSION KIT WAS OPENED, BUT WAS ALSO MISSING TROCARS. THE PROCEDURE WAS COMPLETED WITH THE USE OF A KIRSCHNER WIRE, RESULTING IN A DELAY OF 55 MINUTES.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.