BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/12MM

    MDR report key: 7113801 · Received December 13, 2017

    Report

    Report Number
    8030965-2017-50619
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 15, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819420182
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 04.210.082S, LOT # 8191899: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 10.DEC.2012 EXPIRY DATE: 01.NOV.2022: NO NON-CONFORMANCE REPORTS (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 04.210.082 / 6815123 WAS MANUFACTURED IN US. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 08-NOV-2011: PART NO: 04.210.082, LOT NO: 6815123 (NON-STERILE) ¿ 1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/12MM. QUANTITY (B)(6). COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.032.999, 2.8MM TI SCREW BLANK 32MM. BP55, LOT 6805717 MEET SPECIFICATION. LOT WAS RELEASED TO BP55 ON 31-OCT-2011. INSPECTION SHEET FOR FINAL INSPECTION MEETS INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. REVIEWING DHR SHOWS THAT THIS LOT WAS RELEASED AFTER COMPLETE FINAL INSPECTION WITH NO DETECTED ISSUES REGARDING MANUFACTURING PROCEDURE. THIS BUTTRESS PIN WAS RELEASED IN FAULTLESS CONDITION. AS RECEIVED CONDITION: THE COMPLAINT CONDITION IS CONFIRMED. MICROSCOPIC INVESTIGATION SHOWS CLEARLY THAT THE LOCKING THREAD IS BADLY DAMAGED. THE THREAD IS PLASTICALLY DEFORMED WHAT DOES NOT ALLOW LOCKING THE SCREW HEAD IN THE PLATE AS FORESEEN. ALSO, THE THREAD AT THE PIN SHAFT IS DEFORMED. THIS LED US COME TO THE CONCLUSION THAT THE PIN WAS NOT PROPERLY ALIGNED DURING INSERTION, AS RESULT; THE THREAD CAME INTO HARD CONTACT WITH THE PLATE WHAT FINALLY CAUSED THE REPORTED DAMAGE OF THE THREADS. ALSO DAMAGES / PLASTICALLY DEFORMATION IDENTIFIED AT THE STAR-DRIVE RECESS CLEARLY INDICATES EXCEEDING APPLIED MECHANICAL FORCE WHILE INSERTION. DUE TO THE DEFORMATION / DAMAGE, IT IS NOT POSSIBLE TO MEASURE THE DIMENSION / SHAPE OF THE LOCKING THREADS. THEREFORE, WE CLASSIFY THIS AS HANDLING ERROR WHILE INSERTION. A MANUFACTURING ISSUE CAN BE EXCLUDED. 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: PATIENT INFORMATION IS UNKNOWN. (B)(4). DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SCREW WAS USED IN THE SURGERY FOR THE DISTAL RADIUS FRACTURE ON (B)(6) 2017. AT THE MOST RADIAL SIDE THE SCREW PENETRATED THROUGH THE SCREW HOLE. THE OPERATION WAS COMPLETED SUCCESSFULLY BY REPLACING IT WITH A NEW SCREW. THE SURGERY WAS EXTENDED FOR TEN (10) MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. CONCOMITANT PART: IMPLANT (PART/LOT UNKNOWN, QUANTITY 1). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895321 1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/12MM SCREW, FIXATION, BONE HWC OBERDORF : SYNTHES PRODUKTIONS GMBH 8191899 07611819420182

    Patients

    Seq Age Sex Outcome Treatment
    1