MEDLINE RENEWAL

Additional Manufacturer Narrative

SUPPLEMENTAL DOCUMENTATION CHANGED/ADDITIONAL INFORMATION ADDED. D9 DEVICE AVAILABLE FOR EVALUATION -N/A G6 TYPE OF REPORT - FOLLOW-UP. H2 IF FOLLOW-UP WHAT TYPE? ADDITIONAL INFORMATION, DEVICE EVALUATION. H3 DEVICE EVALUATED BY MANUFACTURER - YES, EVALUATION SUMMARY ATTACHED. H6 TYPE OF INVESTIGATION- 10 H5 INVESTIGATION CONCLUSION - ZCD00007/NOT A PRODUCT DEFECT. H10 INVESTIGATION REPORT READS AS FOLLOWS: 06/22/2021 16:23:16 CST ((B)(6) ) "INVESTIGATION: ONE DEVICE WAS RECEIVED FROM MERIT HEALTH RIVER OAKS ON 5/28/2021. THE DEVICE WAS CONFIRMED TO BE DYONICS PLATINUM, INCISORPLUS BLADE, (SLATE) 4.5MM, PART # 72203013. THE MEDLINE RENEWAL PACKAGE WAS NOT RETURNED WITH THE DEVICES AND NO LOT INFORMATION WAS PROVIDED WHEN THE COMPLAINT WAS INITIATED. UPON INSPECTION OF THE DEVICE HUB, IT WAS OBSERVED THAT THE DEVICE HAD ONE MEDLINE RENEWAL REPROCESSING MARK. DURING THE INVESTIGATION, THE DEVICE WAS INSPECTED FOR NON-CONFORMITIES PER INTERNAL PROCEDURE. UPON INSPECTION, IT WAS OBSERVED THAT THE DEVICE SHAFT HAD COMPLETELY SEPARATED FROM THE HUB. UPON FURTHER INSPECTION OF THE DEVICE, THERE WERE SEVERAL LARGE CRACKS OBSERVED ON THE OUTER HUB. THE CRACKING OBSERVED WAS LARGER THAN OUR INSPECTION CRITERIA ALLOWS. ADDITIONALLY, RESIDUAL LUBRICANT COULD BE SEEN LEAKING OUT FROM THE BASE OF THE HUB, INDICATING THAT THE DEVICE HAD INTERNALLY SEPARATED. THE REPORTED ISSUE WAS CONFIRMED WITH THE RECEIVED DEVICE. DURING REPROCESSING, ALL DYONICS PLATINUM SHAVERS ARE INSPECTED PER THE FOLLOWING CRITERIA. PER RN1-00098-A-00002 (REVISION 9) DOCUMENT WORK INSTRUCTION: REFURBISHING & PRIMARY INSPECTION - ARTHROSCOPIC SHAVERS AND BURS: IMPORTANT! DYONICS PLATINUM MODELS MUST BE IN PRISTINE CONDITION WITH NO VISIBLE EFFECTS OF USE. A REVIEW OF THE DEVICE HISTORY RECORD OR STOCK CHECK COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. ROOT CAUSE: THE EXACT ROOT CAUSE OF THE DAMAGED DEVICE HUB COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE OF THE CRACKED HUB WAS DUE TO EXCESSIVE SIDE FORCE BEING APPLIED TO THE SHAVERS DURING USE. WHEN SIDE FORCE IS APPLIED TO A DYONICS SHAVER, THE SHAVER MAY CRACK WHERE THE OUTER SHAFT AND HUB MEET. THIS ISSUE CAN OCCUR ON OEM SHAVERS AS WELL AS REPROCESSED SHAVERS. CONCLUSIONS: UPON INITIAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE SHAFT HAD COMPLETED SEPARATED FROM THE HUB. UPON FURTHER INSPECTION, SEVERAL LARGE CRACKS WERE OBSERVED AT THE BASE OF THE HUB/HUB COLLAR. THE REPORTED ISSUE WAS CONFIRMED WITH THE RECEIVED DEVICE."

Description of Event or Problem

IT WAS REPORTED, "ITEM BROKE INTO PIECES."

Additional Manufacturer Narrative

IT WAS REPORTED, "ITEM BROKE INTO PIECES." EMAIL RECEIVED BY (B)(6), FACILITY REPRESENTATIVE AT (B)(6), WHO PROVIDED ADDITIONAL INFORMATION IN REGARDS TO THIS INCIDENT. REPORTER STATES, "INCIDENT OCCURRED ON (B)(6) 2021, DURING A SHOULDER ARTHROSCOPY. SURGEON WAS USING THE PLATINUM BLADE WHEN IT BROKE OFF IN THE CANNULA. SURGEON HAD TO REMOVE SHAFT OF BLADE FROM PATIENT/TROCAR." REPORTER STATES, PROCEDURE TIME DID EXCEED THE EXPECTED TIME BECAUSE OF THIS INCIDENT. REPORTER STATES, NO SERIOUS INJURY OR HARM IS/WAS REPORTED TO THE PATIENT. REPORTER IS "NOT SURE" HOW THE PATIENT IS DOING AT THIS TIME. PHOTOGRAPH AND SAMPLE ARE AVAILABLE FOR RETURN AND EVALUATION. DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MED WATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MED WATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED, "ITEM BROKE INTO PIECES."