BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 46MM FOR IM NAILS

    MDR report key: 6941795 · Received October 11, 2017

    Report

    Report Number
    1000562954-2017-10231
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Report Date
    September 12, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HWC
    UDI-DI
    07611819760271
    PMA / PMN Number
    K000089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 1X 04.005.536 LOT 9113918 FORWARDED TO MANUFACTURING PLANT (B)(4) FOR INVESTIGATION: AS RECEIVED CONDITION OF DEVICES: TWO SCREWS HAVE BEEN RECEIVED NOT IN THE ORIGINAL PACKAGING: THE INFORMATION ETCHED ON PRODUCTS MATCH TO COMPLAINT SYSTEM AND DHR. THE SCREWS ARE BROKEN IN THE MIDDLE OF THE SHAFT. DHR REVIEW: LOT 9113918 WAS MANUFACTURED IN AUG 2014. ALL THE INSPECTIONS PERFORMED ACCORDING TO INSPECTION SHEET PASSED. NO NCRS WERE GENERATED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE CERTIFICATES OF THE RELATED RAW MATERIALS USED TO MANUFACTURE THE PLATE HAVE BEEN REVIEWED. LOT 9113918 WAS MANUFACTURED STARTING FROM RAW MATERIAL LOT 16149. IN THE RELATIVE CERTIFICATES IT IS REPORTED THAT THE MATERIAL IS CONFORMING. PRODUCT INSPECTION: ALL THE MEASURABLE FEATURES PERTINENT TO COMPLAINT CONDITION HAVE BEEN FOUND CONFORMING TO SPEC. THE TWO RETURNED ITEMS ARE SERIOUSLY DAMAGED POST PRODUCTION AND BROKEN IN THE MIDDLE OF THE SHAFT: NO EVIDENCE OF NONCONFORMANCE MANUFACTURING RELATED. THE RAW MATERIAL HAS BEEN VERIFIED THROUGH REVIEW OF CERTIFICATE DOCUMENTED IN THE DHR REVIEW. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. CONCOMITANT PARTS: BELOW LISTED ARTICLES RATED AS CONCOMITANT PARTS. THEY ARE IN GOOD CONDITION AND NO INVESTIGATION WAS PROVIDED ON THEM. 1X 04.038.000S / 9830638 (TFNA END CAP EXTENS. 0 TAN); 1X 04.038.095S / 9872264 (TFNA SCR L95 TAN). 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 IDENTIFIER, DATE OF BIRTH, AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF DEVICE BREAKAGE IS NOT KNOWN. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.005.536, LOT# 9113918. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: AUG 25, 2014. 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. MANUFACTURING EVALUATION WAS COMPLETED. DEVICE WAS NOT RETURNED IN THE ORIGINAL PACKAGING. THE INFORMATION ETCHED ON THE PRODUCTS MATCHED TO THE DEVICE HISTORY RECORDS. THE RECEIVED SCREW WAS BROKEN IN THE MIDDLE OF THE SHAFT. LOT 9113918 WAS MANUFACTURED IN AUG 2014. ALL THE INSPECTIONS PERFORMED ACCORDING TO RELEVANT INSPECTION SHEET AND HAVE PASSED. 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. THE CERTIFICATES OF THE RELATED RAW MATERIALS USED TO MANUFACTURE THE PLATE HAVE BEEN REVIEWED. LOT 9113918 WAS MANUFACTURED STARTING FROM RAW MATERIAL LOT 16149. IN THE RELATIVE CERTIFICATES, IT IS REPORTED THAT THE MATERIAL IS CONFORMING. THE RECEIVED DEVICE WAS INSPECTED FOR ALL THE FEATURES PERTINENT TO THE COMPLAINT CONDITION ACCORDING TO THE PRODUCT INVESTIGATION MATRIX ¿BROKEN/CRACKED¿. ALL THE MEASURABLE FEATURES PERTINENT TO COMPLAINT CONDITION HAVE BEEN FOUND CONFORMING TO SPECIFICATIONS. COMPLAINT IS CONFIRMED DUE TO THE EVIDENCE THAT THE PART IS BROKEN. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED IN THE SURGERY FOR THE LEFT FEMORAL SUB-TROCHANTERIC FRACTURE ON (B)(6) 2016. THE TFNA (TROCHANTERIC FEMORAL NAIL ADVANCED) LONG WAS USED THEN. ONE YEAR AFTER THAT, THE PATIENT SOUGHT MEDICAL ATTENTION DUE TO LEG PAIN. IT WAS ALSO FOUND THAT THE NAIL HAD BEEN BROKEN. ON (B)(6) 2017, THE REVISION SURGERY BY A DHS (DYNAMIC HIP SCREW) REPLACEMENT WITH CABLE FIXATION WAS PERFORMED SAFELY. SURGEON NOTED A POSSIBLE REDUCTION FAILURE FROM THE PRIMARY SURGERY. THE SURGEON ALSO ADDED THAT, EVEN THOUGH THE PATIENT WAS TRANSFERRED TO A REHABILITATION HOSPITAL AFTER THE PRIMARY SURGERY, HE WALKED ARBITRARILY WITHOUT FOLLOWING THE REHABILITATION INSTRUCTIONS AND FELL EVENTUALLY. IT WAS UNCERTAIN WHEN THE NAIL WAS BROKEN EXACTLY SINCE THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION FOR A WHILE. THE MEDICAL FOLLOW-UP WAS PLANNED AND SUCCESSFULLY COMPLETED. PATIENT OUTCOME OK. TWO SCREWS WERE RECEIVED BROKEN. IT IS UNKNOWN WHEN OR HOW THE SCREWS BROKE. CONCOMITANT DEVICES REPORTED: TI END CAP FOR TFNA 0MM EXTN-STERILE (PART# 04.038.000S, LOT# 9830638, QUANTITY 1). TFNA SCREW 95MM- STERILE (PART# 04.038.095S, LOT# 9872264, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 46MM FOR IM NAILS THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720470 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 46MM FOR IM NAILS SCREW,FIXATION,BONE HWC SYNTHES MEZZOVICO 9113918 07611819760271

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR