BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5745830 · Received June 23, 2016

    Report

    Report Number
    3000270450-2016-10150
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NON-STERILE PART INFORMATION ADDED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED ON THE NON-STERILE PART. THE REPORT INDICATES THAT THE: ARTICLE 04.211.012 WAS MANUFACTURED IN THE US UNDER LOT NUMBER 9800098. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 05-MAY-2015, PART #: 04.211.012, LOT#: 9800098 (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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT INVESTIGATION WAS PERFORMED FOR THE COMPLAINT DEVICE (2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM--STERILE, PART NUMBER 04.211.012S, LOT NUMBER 9725978). THE COMPLAINT DEVICE WAS RECEIVED BY SYNTHES CUSTOMER QUALITY WITH THE COMPLAINT THAT THE SCREW WOULD NOT LOCK TO THE PLATE DURING SURGERY. THE RETURNED IMPLANT IS PART OF THE 2.7MM/3.5MM VARIABLE ANGLE LCP ELBOW SYSTEM. THE SYSTEM IS COMPRISED OF THREE DIFFERENT PLATES THAT ARE INDICATED FOR VARIOUS TYPES OF FRACTURES OF THE OLECRANON AND PROXIMAL ULNA PER THE TECHNIQUE GUIDE. DRAWINGS FOR THE SCREW AND THE REPORTED PLATE WERE REVIEWED DURING THE INVESTIGATION. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. AS PREVIOUSLY REPORTED, A 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. THE LOCKING THREADS OF THE RETURNED SCREWS ARE SEVERELY DAMAGED AND ROLLED. THE DAMAGE IS SUCH THE SCREW COULD NOT LOCK TO THE PLATE. THE ROSE GOLD ANODIZATION HAS BEEN RUBBED OFF IN NUMEROUS LOCATIONS. THE EXACT ROOT CAUSE OF THE COMPLAINT CONDITION COULD NOT BE DETERMINED, BUT IT WAS LIKELY DUE TO APPLYING EXCESSIVE TORQUE DURING INSERTION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE IS HWC. (B)(4). THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORIF (OPEN REDUCTION AND INTERNAL FIXATION) SURGERY TO TREAT A SUPRACONDYLAR HUMERAL FRACTURE ON (B)(6) 2016, TWO 2.7MM VARIABLE ANGLE LOCKING SCREWS WERE NOT ABLE TO BE LOCKED AFTER INSERTION. THE FIRST SCREW WAS INSERTED INTO THE DISTAL HOLE OF THE REPORTED PLATE AND WAS NOT ABLE TO BE LOCKED. THE SURGEON REMOVED THE SCREW FROM THE PLATE HOLE AND REPLACED IT WITH ANOTHER SCREW; HOWEVER, THIS SCREW ALSO DID NOT LOCK AND ONLY IDLED. NEITHER OF THE REPORTED SCREWS WAS IMPLANTED IN THE PATIENT. THE SURGERY WAS EXTENDED FOR 20 MINUTES DUE TO THE EVENT. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THIS REPORT IS 1 OF 2 FOR (B)(46).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400184 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM--STERILE PLATE, FIXATION, BONE HRS SYNTHES SELZACH 9725978

    Patients

    Seq Age Sex Outcome Treatment
    1