BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM

    MDR report key: 6058254 · Received October 26, 2016

    Report

    Report Number
    3000270450-2016-10254
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Report Date
    October 6, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. ADDITIONAL CODE: HWC. (B)(6). (B)(4). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. (STERILE) -ARTICLE WAS STERILIZED BY SUPPLIER (B)(4) WITH LOT NUMBER L040817. ARTICLE 04.211.012 WAS MANUFACTURED IN THE US WITH LOT NUMBER H087845. (NON-STERILE). MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 27-APR-2016, PART #: 04.211.012, LOT #: H087845 (NON-STERILE) - 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM. 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. 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: A PRODUCT INVESTIGATION WAS COMPLETED: DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE REVIEW OF THE DEVICE HISTORY RECORDS SHOWED CONFORMITY TO SPECIFICATIONS. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER, BASED ON THE COMPLAINT DESCRIPTION, POSTOPERATIVE PATIENT NONCOMPLIANCE COULD HAVE CONTRIBUTED TO THE FAILURES. THE RETURNED IMPLANTS ARE PART OF THE 2.7MM/3.5MM VARIABLE ANGLE LCP ELBOW SYSTEM. PER THE TECHNIQUE GUIDE, THE SYSTEM IS COMPRISED OF THREE DIFFERENT PLATES THAT ARE INDICATED FOR VARIOUS TYPES OF FRACTURES OF THE OLECRANON AND PROXIMAL ULNA. TWO 2.7MM VA LOCKING SCREWS, IDENTIFIED AS 04.211.024 AND 04.211.036, WERE RETURNED FRACTURED JUST BELOW THE LOCKING HEAD. BOTH LOCKING HEADS WERE RETURNED, ONE OF WHICH REMAINED LOCKED INTO THE RETURNED VA-LCP DHP 2.7/3.5 POSTEROLATERAL DISTAL HUMERUS PLATE WITH LATERAL SUPPORT. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. MATERIAL WAS RECEIVED BY THE MANUFACTURER ON OCTOBER 06, 2016. IT IS UNKNOWN WHEN THE EXPLANT PROCEDURE OCCURRED. AN EXPLANT DATE OF (B)(6) 2016 WAS REPORTED; HOWEVER, THIS WAS ALSO REPORTED AS THE IMPLANT DATE. IT IS UNKNOWN IF (B)(6) 2016 IS THE IMPLANT OR EXPLANT DATE. 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 AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN HARDWARE REMOVAL PROCEDURE ON (B)(6) 2016, THREE (3) VA-LOCKING SCREWS WERE STUCK INTO THREE (3) SCREW HOLES OF A VARIABLE-ANGLE LOCKING COMPRESSION PLATE DISTAL HUMERUS PLATE (VA-LCP DHP) PLATE. THIS MALFUNCTION MAY HAVE OCCURRED WHILE THE IMPLANTS WERE BEING REMOVED. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS RELATED TO LINKED COMPLAINT (B)(4) WHICH ADDRESS THE NEED FOR A REVISION PROCEDURE FOR BROKEN SCREWS DUE TO THE PATIENT REPEATEDLY HIT THE BODY PART VIOLENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708003 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM SCREW,FIXATION,BONE HWC SYNTHES SELZACH L040817

    Patients

    Seq Age Sex Outcome Treatment
    1