DAVIS BRAIN SPATULA MALL 178X26MM

Description of Event or Problem

ON 07FEB2020, CLARIFICATION WAS RECEIVED: THE SPATULAS WERE "TOO MALLEABLE". THE SURGERY WAS BEING PERFORMED FOR AN ANEURYSM. ONLY 1 DEVICE WAS USED ON THE PATIENT, THE MD111. ALL OF THE MD111 SEEMED TO BE AFFECTED. THE FACILITY WAS UNCERTAIN AS TO HOW OFTEN THE INSTRUMENTS HAD BEEN USED; THE STERILIZATION TYPE WAS NOTED TO BE STEAM. THE NURSE STATED THAT THE OTHER DEVICES WERE JUST THINNER THAN IN PREVIOUS EXPERIENCE. THERE WERE NO REPORTED ALLEGATIONS AGAINST MD112, MD113, MD114, MD115, AND MD116 NOT RETRACTING.

Additional Manufacturer Narrative

ASSOCIATED MEDWATCHES: 2916714-2020-00029 (MD111), 2916714-2020-00030, 2916714-2020-00031, 2916714-2020-00032, 2916714-2020-00033, 2916714-2020-00034. MANUFACTURING SITE EVALUATION: ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.INVESTIGATION ON-GOING, IF AVAILABLE.

Additional Manufacturer Narrative

SUPPLIER: (B)(4) ASSOCIATED MEDWATCHES: 2916714-2020-00029 (MD111), 2916714-2020-00030, 2916714-2020-00031, 2916714-2020-00032, 2916714-2020-00033, AND 2916714-2020-00034. MANUFACTURING SITE EVALUATION: CONDITION OF DEVICE RECEIVED THE COMPLAINT DEVICES WERE RETURNED IN A STERILIZATION POUCH. ONE OF THE SPATULAS DID NOT APPEAR TO HAVE ANY SCRATCHES OR BENDS. THE REST OF THE SPATULAS HAD SCRATCHES AND WERE BENT IN SEVERAL AREAS. ROOT CAUSE INVESTIGATION RESULTS - AS INDICATED HEREIN, WE ONLY RECEIVED THE PRODUCT BACK FOR MD111. THE OTHER REPORTED DEVICES WERE NOT RETURNED FOR OUR INVESTIGATION. THEREFORE, WE CAN ONLY ADDRESS THE ROOT CAUSE INVESTIGATION FOR COMPLAINT (B)(4). UPON RECEIPT OF THE COMPLAINT PRODUCT, A FUNCTIONALITY TEST WAS PERFORMED ON THE DEVICES. THE RESULTS OF THE TEST INDICATED THAT THE MATERIAL THICKNESS FELL WITHIN THE REQUIRED PRODUCT SPECIFICATIONS AND TOLERANCES. THE PRODUCT DRAWINGS WERE INSPECTED AND THERE WEREN'T ANY DESIGN CHANGES THAT HAD TO BE ADDRESSED. BASED ON THESE RESULTS, THE ROOT CAUSE IS DEEMED TO BE CAUSED BY A USER MISUSE. THIS DEVICE IS ONLY 6MM WIDE, THE MOST DELICATE PATTERN OF THE ENTIRE FAMILY OF DAVIS BRAIN SPATULAS, AND IT CANNOT FUNCTION PROPERLY WHEN EXCESSIVE FORCE IS APPLIED, OR WHEN IT IS USED ON AN AREA THAT IS TOO LARGE. DIFFERENT SPATULA SIZES ARE AVAILABLE TO ACCOMMODATE FOR DIFFERENT SURGICAL NEEDS. ROOT CAUSE: USER MISUSE. CORRECTIVE / PREVENTIVE ACTION: A TRENDING ANALYSIS WAS PERFORMED, AND THERE WERE NO PREVIOUS OCCURRENCES OF THIS ISSUE, FOR THIS ITEM. AT THE MOMENT, CORRECTIVE AND PREVENTION ACTION WAS NOT DEEMED AS NECESSARY.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. INVESTIGATION ON-GOING, IF AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE DAVIS SPATULAS. DURING CRANIAL SURGERY, THE SPATULAS WERE NOT HOLDING SHAPE WELL ENOUGH TO RETRACT THE BRAIN TISSUE. THIS INVOLVED A SET OF SPATULAS. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL SET OF RETRACTORS. THERE WAS NO PATIENT HARM. ASSOCIATED MEDWATCHES: 2916714-2020-00029, 2916714-2020-00030, 2916714-2020-00031, 2916714-2020-00032, 2916714-2020-00033, 2916714-2020-00034.