BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRECUTTER SM L160

    MDR report key: 6180524 · Received December 16, 2016

    Report

    Report Number
    9680938-2016-10183
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    November 24, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXZ
    UDI-DI
    07611819024762
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: A SMALL PART AT THE TIP OF ONE LEG IS BROKEN OFF. THERE ARE SOME SCRATCHES AT THE CUTTING EDGES DETECTED. NO OTHER DAMAGES ARE VISIBLE. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR CRITICAL FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 15-JUL-2016. NO NCRS WERE GENERATED DURING PRODUCTION. UNFORTUNATELY WITHOUT MORE INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE. THIS KIND OF DAMAGE CAN OCCURRED WHILE USING THE INSTRUMENT JUST ON THE FRONT PART OF THE CUTTING EDGES. 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

    THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    NO PATIENT INVOLVEMENT WAS REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 391.900, LOT# T127239. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: FEB 15, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL PARTS OF THE LOT WERE CHECKED FOR CRITICAL FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON JUL 15, 2016. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6), AS FOLLOW: IT WAS REPORTED THAT CUTTING AREA OF A WIRE CUTTER WAS DEFECTIVE AS THE SMALL PIECES OF DEVICE BROKE OFF. IT IS UNKNOWN WHEN THE ISSUE OCCURRED OR WHEN IT WAS DETECTED. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) WIRE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833067 WIRECUTTER SM L160 CUTTER,WIRE HXZ SYNTHES TUTTLINGEN T127239 07611819024762

    Patients

    Seq Age Sex Outcome Treatment
    1