DISPOSABLE BANANA BLADE

Additional Manufacturer Narrative

CONMED LINVATEC RECEIVED THE BROKEN BLADE IN TWO DISTINCT PIECES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DISPOSABLE BANANA BLADE CONFIRMED THE REPORTED BREAKAGE AND FOUND THE BLADE WAS SEPARATED FROM THE SHAFT. MICROGRAPH EXAMINATION REVEALED THE BROKEN BLADE EXHIBITED SOME AMOUNT OF WEAR TO THE CUTTING SURFACE (NICKS) AND THE WEAR WAS CONSIDERED TO BE CONSISTENT WITH A PRODUCT THAT HAD BEEN USED SEVERAL TIMES. FURTHER EVALUATION FOUND THE SHAFT HANDLE PRESENTED WITH RUST-LIKE AREAS SCATTERED ACROSS THE HANDLE SURFACE. MICROGRAPH ANALYSIS IN THE AREA OF SEPARATION BETWEEN THE BLADE AND SHAFT HANDLE REVEALED A FRACTURED METAL BREAK WITHOUT SIGNIFICANT DISTORTION TO THE GEOMETRY OF THE TWO PIECES. A LOCALIZED AREA OF DENSE DISCOLORATION AND RUST-LIKE APPEARANCE THAT REMAINED IN THE CROSS-SECTION OF THE FRACTURE WAS NOTED. THIS SUGGESTS THAT THE BLADE HAD BEEN CRACKED OR PARTIALLY SEPARATED, ALLOWING CHEMICALS TO INTRUDE INTO THE PARTIAL BREAK. ONCE TRAPPED THESE COULD CONTRIBUTE LOCALIZED RUSTING LEADING TO A CLEAN BREAK AT A LATER TIME UNDER FAR LESS STRESS. ALL OF THESE FACTORS STRONGLY INDICATE THAT THIS SINGLE-USE PRODUCT HAS BEEN USED MORE THAN ONE TIME. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED LOT #391348 WAS MANUFACTURED ON AUGUST 20, 2012 IN A LOT OF (B)(4) UNITS WITH NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED BREAKAGE. IN ADDITION, THERE WERE NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. THIS PRODUCT IS INTENDED TO CUT SOFT, THICK TISSUE DURING HIP ARTHROSCOPY. THIS FAILURE MODE IS ADDRESSED IN THE RISK DOCUMENT AS AN ACCEPTABLE RISK. A LETTER OF EDUCATION REGARDING THIS TYPE OF BREAKAGE ALONG WITH THE EVALUATION RESULTS WILL BE FORWARDED TO THE CUSTOMER.

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING USE OF THE HSP-BLD (DISPOSABLE BANANA BLADE) IN A HIP ARTHROSCOPY ON A (B)(6), FEMALE PATIENT, THE TIP OF THE BLADE BROKE OFF INSIDE THE JOINT AND COULD NOT BE FOUND/REMOVED. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITH A PLAN FOR A POST-OPERATIVE SURGERY TO LOCATE AND REMOVE THE BROKEN TIP AT A LATER TIME. SUBSEQUENTLY, A SECOND SURGERY WAS PERFORMED ONE WEEK LATER ON (B)(6) 2013 AND THE TIP WAS SUCCESSFULLY REMOVED AT THAT TIME. FOLLOW-UP WITH THE USER FACILITY REVEALED THAT THE USER REUSED THIS "SINGLE USE" DISPOSABLE BANANA BLADE. NAME AND ADDRESS OF THE REPROCESSOR WAS NOT PROVIDED. LATEST FOLLOW-UP WITH THE CUSTOMER INDICATED THAT THERE ARE NO SIDE EFFECTS OR INFECTIONS ON THE PATIENT'S HIP AND SHE IS DOING FINE AT THE PRESENT TIME.

Additional Manufacturer Narrative

TO DATE THE DEVICE HAS NOT BEEN RETURNED FROM THE USER FACILITY FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION. DEVICE HAS NOT YET BEEN RETURNED.