BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM THREADED GUIDE WIRE

    MDR report key: 7245318 · Received February 6, 2018

    Report

    Report Number
    8030965-2018-50898
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 15, 2018
    Report Date
    January 15, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    LRN
    UDI-DI
    07611819733121
    PMA / PMN Number
    PREAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY . PART NUMBER: 292.620S , SYNTHES LOT NUMBER: L221168 , RELEASE TO WAREHOUSE DATE: 05.DEC.2016 EXPIRY DATE: 01.NOV.2026 , SUPPLIER: (B)(4), MANUFACTURING SITE: (B)(4). 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: PART NUMBER: 292.620 , SYNTHES LOT NUMBER: L211237 , RELEASE TO WAREHOUSE DATE: 22.NOV.2016 , MANUFACTURING SITE: (B)(4). 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: THE THREADED TIP OF THE GUIDE WIRE IS BROKEN OFF AT THE SECOND THREAD FLANK BELOW THE SHAFT. THERE ARE CLEARLY VISIBLE STRESS MARKS AT THE SHAFT AND THE MARKINGS ARE BARELY READABLE DUE TO THE MARKS. ALSO, WE FOUND THAT THE SHAFT IS BENT. THE BROKEN TIP WAS SEND BACK FOR EVALUATION, THE THREAD FLANKS AT THE TIP ARE COMPLETELY FLATTENED AND THE CUTTING EDGES AT THE FOREFRONT ARE BLUNT. THE REMAINING THREAD FLANKS AT THE SHAFT ARE ALSO FLATTENED, THEREFORE THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. THUS, THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES COULD BE DETECTED. THERE WAS NO DEVIATION REGARDING DIMENSION OR MATERIAL (STAINLESS STEEL ACCORDING TO ISO 5832-1). BASED ON THE OVERALL CONDITION OF THE GUIDE WIRE WE HAVE TO ASSUME THAT A MECHANICAL OVERLOAD DURING USE DID LEAD TO THE BREAKAGE OF THE DEVICE. ACCORDING TO THE DESCRIPTION WAS THE WIRE INSERTED INTO SOLID BONE SEVERAL TIMES, THIS LET US ASSUME THAT THE TIP AND THE THREAD FLANKS DID GET BLUNT BY THESE MULTIPLE ATTEMPTS, WHICH FINALLY CAUSED THE OVERLOAD. IN GENERAL, WE WOULD LIKE TO POINT OUT THAT THE GUIDE WIRE 292.620 IS A SINGLE USE DEVICE AND SHOULD THEREFORE NOT BE RE-USED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART HAS NOT BEEN RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    IT WAS REPORTED THAT THE TIP OF A GUIDE WIRE BROKE IN SURGERY FOR A DISTAL TIBIA FRACTURE ON (B)(6) 2018. IT TOOK 30 MINUTES TO REMOVE THE BROKEN FRAGMENT, AND THE SURGERY WAS COMPLETED WITHOUT ANY OTHER PROBLEMS. AS THE PATIENT HAS SOLID BONE QUALITY, THE SURGEON TRIED TO INSERT THE GUIDE WIRE SEVERAL TIMES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR A GUIDE WIRE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87398 1.25MM THREADED GUIDE WIRE WIRE,SURGICAL LRN OBERDORF : SYNTHES PRODUKTIONS GMBH L221168 07611819733121

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR