BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.7MM CABLE WITH CRIMP 750MM-STERILE

    MDR report key: 6382813 · Received March 6, 2017

    Report

    Report Number
    3000270450-2017-10075
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 8, 2017
    Report Date
    February 8, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDQ
    PMA / PMN Number
    K992616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE BROKEN CABLE WAS NOT RETURNED; HOWEVER TWO CABLE TENSIONERS (PART 03.221.015, LOT P162067) WERE RECEIVED AND INVESTIGATED. FUNCTIONAL TESTING FOR THE TENSIONERS CONFIRMED THAT BOTH ARE READING SLIGHTLY LOWER THAN THE EXPECTED. THE MEASUREMENTS CONFIRM THAT THE TENSIONERS DO NOT MEET MANUFACTURING TENSION SPECIFICATIONS. HOWEVER, DUE TO THE LOWER TENSION READINGS, IT HAS BEEN DETERMINED THAT THE TENSIONERS WOULD NOT INFLICT THE TYPE OF DAMAGE TO THE CABLES THAT HAS BEEN REPORTED IN THIS COMPLAINT. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT IT IS LIKELY THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. NO PRODUCT FAULT COULD BE DETECTED. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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: (B)(6). (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY 298.801.01S / 9588493; MANUFACTURING LOCATION: (B)(4); SUPPLIER: (B)(4); MANUFACTURING DATE: 03.AUG.2015; EXPIRY DATE: 01.JUL.2025. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE 404.034 / 8535031; 298.801.01 / P211378; MANUFACTURING LOCATION: USA / (B)(4). DHR FOR THE NON-STERILE PART: DHR REVIEW FOR PART #298.801.01, LOT #P211378; RELEASE TO WAREHOUSE DATE: 15-JUN-2015; EXPIRATION DATE: NA; SUPPLIER: RTI SURGICAL. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION 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 ON AN EVENT IN (B)(6) AS FOLLOWS: T WAS REPORTED THAT DURING SURGERY ON USING THE CERCLAGE CABLES WITH THE MIPO GUN, THREE CABLE FRAYED AND ONE OF THEM SHATTERED INTO SMALL PIECES BREAKING OFF INTO THE PATIENT. THEY USED THEN THE CYLINDER TENSIONER AND THE REST WENT FINE. THE SURGEON DID NOT OVERTIGHTEN THE CABLES ALTHOUGH THEY FAILED DURING TENSIONING. THE SURGERY WAS COMPLETED WITH NO ADVERSE OUTCOME TO THE PATIENT OR NO PATIENT HARM. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION. THERE IS POSSIBLY ALSO AN ALLEGATION AGAINST THE MIPO GUN. THE SURGEON WAS CONFIDENT THAT ALL SHARDS WERE REMOVED. THEY WERE OF RETRIEVABLE SIZE AND WERE SUPERFICIAL. THIS COMPLAINT INVOLVES 4 PARTS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162984 1.7MM CABLE WITH CRIMP 750MM-STERILE CERCLAGE FIXATION JDQ SYNTHES SELZACH 9588493

    Patients

    Seq Age Sex Outcome Treatment
    1