SURG PAT XRAY 1/2X1/2

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE PATTIES COULD NOT BE SEEN UNDER X-RAY. THE SURGEON WAS CONDUCTING A ROUTINE X-RAY AND HE KNEW THE PATTIES WERE THERE BUT THEY WERE NOT VISIBLE. ADDITIONAL INFORMATION FROM THE CUSTOMER STATED WHEN THE SURGEON ALSO CONDUCTED AN AP AND LATERAL X-RAY UNDER FLUORO WITH THE C-ARM THE INSTRUMENT WAS LAID NEAR THE PATTY AND THE INSTRUMENT WAS VISIBLE BUT THE PATTIES WERE NOT. AN X-RAY WAS ALSO CONDUCTED WITH JUST A STACK OF PATTIES IN THE PACKAGE AND THEY DID NOT SHOW UP. THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAY IN SURGERY GREATER THAN 30 MINUTES.

Additional Manufacturer Narrative

UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative

UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE COMPLAINT SAMPLES WERE SENT FOR TESTING FROM BOTH LOTS. TESTING WAS CONDUCTED PER THE REQUIREMENTS. ALL SAMPLES PASSED THE REQUIREMENTS OF THE TESTS. THE COMPLAINT COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE COULD NOT BE DETERMINED. PER THE INSTRUCTIONS FOR USE, THE DOCUMENT INDICATES THAT "THIS DEVICE IS CONSIDERED RADIOPAQUE IN ACCORDANCE WITH ASTM F640. THE DEVICE MAY NOT BE VISIBLE UNDER ALL RADIOGRAPHIC CONDITIONS." ¿THE SIZE AND POSITION OF THE MARKER MAY IMPACT RADIOPACITY. IN ADDITION, ADJACENT STRUCTURES MAY INHIBIT VISIBILITY. MULTIPLE ANGLES AND MODIFICATION OF RADIOGRAPHY PARAMETERS (E.G. KEVM MAS) MAY BE REQUIRED TO ENHANCE VISIBILITY OF THE MARKER." BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

Additional Manufacturer Narrative

4/17/14 WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.

Description of Event or Problem

CUSTOMER REPORTED THAT THE PATTIES COULD NOT BE SEEN UNDER X-RAY. THE SURGEON WAS CONDUCTING A ROUTINE X-RAY AND KNEW THE PATTIES WERE THERE AND NOTICED THE PATTIES WERE NOT VISIBLE. THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAY IN SURGERY GREATER THAN 30 MIN. CUSTOMER WILL BE RETURNING UNUSED PRODUCT FOR INVESTIGATION. WHEN THE SURGEON WAS PERFORMING THE SURGERY HE DID A AP AND LATERAL X-RAY UNDER FLEURO WITH THE C-ARM. THE DOC LAYED THE INSTRUMENT NEAR THE PATTIE AND THE INSTRUMENT WAS VISABLE, BUT THE PATTIES WERE NOT. ALSO, THE NURSE ALSO CONDUCTED AN X-RAY WITH JUST A STACK OF PATTIES IN THE PACKAGE AND THEY DID NOT SHOW UP. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.