BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL BLADE 5MM

    MDR report key: 4973211 · Received August 5, 2015

    Report

    Report Number
    9680938-2015-10071
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    December 4, 2014
    Report Date
    August 3, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    FZO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT INVESTIGATION SUMMARY: TWO CHISEL BLADES, 5MM (PART 399.58 / LOT T992128) WERE RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKE DURING A LEFT TOTAL HIP REPLACEMENT.¿ IT WAS REPORTED THAT THEY WERE RETRIEVED BY THE SURGEON. THE COMPLAINT CONDITION IS CONFIRMED AS RETURNED DEVICES WERE EACH RECEIVED WITH THE DISTAL CUTTING EDGE BROKEN OFF OF THE MAIN BODY OF THE DEVICES. THE RETUNED CONDITION IS CONSISTENT WITH EXTENSIVE ACCUMULATED WEAR FROM ROUTINE USE OF EXCESSIVE FORCE AND/OR IMPACT. IT IS MOST PROBABLE THAT THE METHOD OF MAINTENANCE AND ACCUMULATED WEAR RESULTED IN THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE RETURNED CHISEL BLADES / LOT NUMBER T992128. THE DEVICES WERE FOUND TO HAVE BEEN MANUFACTURED IN MAY, 2013. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL, WHICH WAS DELIVERED AS LOT U72188 IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING BETWEEN 59.3-59.7 HRC AND WAS FOUND TO BE GOOD. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. FURTHER EVALUATION SHOWS THAT THESE DEVICES ARE USED WITH A CHISEL HANDLE (PART 399.54) AND ARE PART OF THE HIP PRESERVATION SURGERY SET. THIS SET IS DESIGNED TO ASSIST THE SURGEON WITH PERIACETABULAR OSTEOTOMY AND HIP IMPINGEMENT PROCEDURES. INFORMATION IS PROVIDED THE HIP PRESERVATION SURGERY SET TECHNIQUE GUIDE. THE RETURNED DEVICES WERE EACH RECEIVED WITH THE DISTAL CUTTING EDGE BROKEN OFF OF THE MAIN BODY OF THE DEVICES. AS THE PART AND LOT NUMBERS ARE IDENTICAL THE FIRST DEVICE WILL BE REFERENCED AS DEVICE A AND THE SECOND DEVICE WILL BE REFERENCED AS DEVICE B. THE BREAKS ARE TRANSVERSE AND LOCATED 65.3 MM FROM THE PROXIMAL END ON DEVICE A AND 62.5MM ON DEVICE B. THE FRACTURE SITES WERE EXAMINED AND NO MATERIAL VOIDS OR IRREGULARITIES WERE IDENTIFIED WHICH MAY HAVE POTENTIALLY COMPROMISED THE INTEGRITY OF THE DEVICE. THE SURFACE OF EACH DEVICE SHOWS SIGNIFICANT SCRATCHES AND THE DISTAL TIP OF EACH DEVICE IS NO LONGER THE STRAIGHT SHARP EDGE AS PER THE DESIGN DRAWING. THE DISTAL END SHOWS SEVERE WEAR AND DEFORMATION. DEVICE B ALSO SHOWS A BEND OF THE DEVICE AT THE FRACTURE LOCATION. A REVIEW OF THE CURRENT DESIGN DRAWING/MANUFACTURED REVISION WAS PERFORMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL AWARENESS DATE FOR THIS COMPLAINT WAS CONFIRMED TO BE (B)(6) 2015. THE DATE INITIALLY REPORTED ((B)(6) 2015) WAS THE DATE THE REPORTER (HOSPITAL EMPLOYEE) BECAME AWARE OF THE INCIDENT. THE MANUFACTURER WAS NOT NOTIFIED OF THE ISSUE UNTIL (B)(4) 2015. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO CHISEL BLADES BROKE DURING A LEFT TOTAL HIP REPLACEMENT. IT WAS REPORTED THAT THEY WERE RETRIEVED BY THE SURGEON. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513251 CHISEL BLADE 5MM CHISEL, SURGICAL INSTRUMENT FZO SYNTHES TUTTLINGEN T992128

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR