BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW 20.1X21.4X4.0X0.6MM FOR PIEZOELECTRIC SYSTEM-STER

    MDR report key: 6891515 · Received September 25, 2017

    Report

    Report Number
    8030965-2017-15030
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 3, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWE
    PMA / PMN Number
    K100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES MANUFACTURING LOCATION WAS UPDATED. UDI: (B)(4). DEVICE HISTORY RECORDS REVIEW WAS PERFORMED. THE REPORT INDICATES THAT THE: MANUFACTURING DATE: DEVICE RECEIVED IN SYNTHES (B)(4) ON 21.12.2015, SHELF LIFE EXPIRY DATE: 01.07.2020, MANUFACTURING LOCATION: SUPPLIER ((B)(4)), BUSINESS GROUP: POWER TOOLS. 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

    REPORTER PHONE NUMBER: (B)(4). 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT ID, AGE, DOB & WEIGHT NOT PROVIDED FOR REPORTING. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS ATTEMPTED. (B)(4). DEVICE 03.000.402S IS A BATCH NUMBER CONTROLLED PRODUCT, THEREFORE NO SERVICE HISTORY RECORD REVIEW IS POSSIBLE. DEVICE HISTORY RECORD REVIEW RESULT BELOW. NO NCRS WERE REFERENCED TO THE DEVICE PART #: 03.000.402S LOT #: 0864712. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES IDENTIFIED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE CONCLUSION OF THE DHR REVIEW IS THAT THE FINAL PRODUCTS MET INSPECTION REQUIREMENTS, CERTIFICATION TEST VALUES, AND ACCEPTANCE CRITERIA. PURCHASE ORDER NR FOR REFERENCE: (B)(4). 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 FURTHER REPORTED THAT THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY DURING THE PROCEDURE. ANOTHER SAW WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE. PATIENT OUTCOME FOLLOWING THE SURGERY IS REPORTED AS STABLE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A DENTAL EXTRACTION IT WAS DISCOVERED THAT THE SAW FOR A PIEZOELECTRIC SYSTEM HAD A CRACKED TIP. THIS COMPLAINT IS FOR ONE (1) DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671208 SAW 20.1X21.4X4.0X0.6MM FOR PIEZOELECTRIC SYSTEM-STER INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH AWL HWE SYNTHES SELZACH 0864712

    Patients

    Seq Age Sex Outcome Treatment
    1