BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6664003 · Received June 23, 2017

    Report

    Report Number
    3000270450-2017-10207
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Date of Event
    May 29, 2017
    Report Date
    May 30, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. POTENTIAL LOT NUMBERS L200860 OR L357449 PROVIDED. IT IS UNKNOWN WHICH LOT WAS THE COMPLAINED DEVICE. UDI: (B)(4)L200860 OR (B)(4)L357449. IMPLANT AND EXPLANT DATES: DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER FACILITY PHONE NUMBER: (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED ON BOTH POTENTIAL LOT NUMBERS: STERILE PART 04.211.012S, LOT L200860: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: NOVEMBER 18, 2016. EXPIRY DATE: NOVEMBER 01, 2026. NON-STERILE PART 04.211.012, LOT H216559. STERILE PART 04.211.012S, LOT L357449: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: MARCH 27, 2017. EXPIRY DATE: MARCH 01, 2027. NON-STERILE PART 04.211.012, LOT H302389. THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY. NO NON-CONFORMANCE REPORTS 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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR NON-STERILE PART# 04.211.012, LOT# H216559. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 29, 2016. COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.012.999 2.8MM TI SCREW BLANK 12MM. BP55, LOT H199442 MEET SPECIFICATION. INSPECTION SHEET FOR FINAL INSPECTION, MILL SHAFT THREADS, TURN/THREAD HEAD, FLUTE FINAL INSPECTION MEET INSPECTION ACCEPTANCE CRITERIA. PART# 04.211.012, LOT# H302389. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: MAR 03, 2017. COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.012.999 2.8MM TI SCREW BLANK 12MM. BP55, LOT H290946 MEET SPECIFICATION. INSPECTION SHEET FOR FINAL INSPECTION, MILL SHAFT THREADS, TURN/THREAD HEAD, FLUTE FINAL INSPECTION MEET INSPECTION ACCEPTANCE CRITERIA. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. 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

    A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT THE: INVESTIGATION CONDUCTED BY THE MANUFACTURING PLANT (B)(4). 1X ARTICLE 04.117.004S WITH LOT L264837 / VA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT RETURNED AND FORWARDED TO MANUFACTURING PLANT RARON FOR INVESTIGATION: AS RECEIVED CONDITION OF DEVICE: MARKS AND SCRATCHES ARE VISIBLE ON THE SURFACE. THE DEVICE-HISTORY-RECORD (DHR) DOES NOT SHOW ANY ABNORMALITIES. EVERYTHING WAS PRODUCED IN SPECIFICATION AS IT SHOULD. MEASUREMENTS OF THE CRITICAL FEATURES WERE TAKEN ON THE COMPLAINT PART. THIS CONFIRMED THE RESULTS OF THE DHR. THE PLATE (VA-LCP DIST HUMERUSPL 2.7/3.5 DORSO-LAT / ARTICLE # 04.117.004S / LOT # L264837) WAS PRODUCE AS IT SHOULD. NO ABNORMALITY IN PROCESS WAS FOUND. BASED ON THIS, THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. IT IS LIKELY THAT THE SCREW HEAD THREAD MUST HAVE BEEN DAMAGED DUE SEVERAL TIMES INSERTION AND IDLING OF THE SCREW BY THE ATTEMPT TO LOCK IT IN THE VA-LCP DHP 2.7/3.5 PLATE. 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: IT WAS REPORTED THAT THE DEVICES WERE USED IN SURGERY FOR DISTAL HUMERAL FRACTURE ON (B)(6) 2017. THE VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE DISTAL HUMERUS PLATE COULD NOT BE LOCKED WHEN THE VARIABLE ANGLE LOCKING SCREW 12 MM WAS INSERTED TO THE MOST DISTAL HOLE (ULNAR SIDE) OF THE PLATE. HOWEVER, THE DISTAL HUMERUS PLATE IN QUESTION COULD BE LOCKED WHEN THIS LOCKING SCREW WAS INSERTED TO THE MOST DISTAL HOLE (RADIAL SIDE). THE SURGEON RE-POSITIONED THE PLATE IN QUESTION. WHEN THE LOCKING SCREW WAS INSERTED AGAIN TO THE DISTAL TWO HOLES (ULNAR AND RADIAL SIDES), THE PLATE COULD NOT BE LOCKED IN EITHER HOLE. ANOTHER DISTAL PLATE WITHOUT A SUPPORT WAS TRIED DURING PROCEDURE; IT COULD NOT BE LOCKED WITH THE LOCKING SCREWS 12 MM IN THE DISTAL HOLES. WHEN OTHER SCREWS WERE USED, THE PLATE WITHOUT THE SUPPORT WAS LOCKED. THE SURGERY WAS EXTENDED FOR TWENTY (20) MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443850 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM PLATE, FIXATION, BONE HRS SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1