BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS

    MDR report key: 6342630 · Received February 19, 2017

    Report

    Report Number
    1000562954-2017-10013
    Event Type
    Injury
    Date Received
    February 19, 2017
    Report Date
    January 24, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HSB
    UDI-DI
    07611819759923
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION (MIA) WAS PERFORMED FOR THE SUBJECT DEVICE 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS, PART 04.005.422, LOT 9286948. RETURNED 1 INTACT NAIL REFERRED IN THE MIA-014280, 2 BROKEN SCREWS REFERRED IN THE MIA-014281 AND MIA-014282, AND TWO OTHER INTACT SCREWS WHICH ARE NOT PARTS OF THE MIAS: PARTS NOT RECEIVED IN THE ORIGINAL PACKAGING. ACCORDING COMPLAINT DESCRIPTION, A NAIL BROKE AT THE OCCUPIED SCREW HOLE. NOT EVERY SCREW IS INTACT. AS RECEIVED CONDITION FURTHER DETAILS THE NAIL IS NOT BROKEN DIFFERENTLY FROM THE COMPLAINT DESCRIPTION, SCREW IS BROKEN (ONE SCREW TIP PORTION IS MISSING). SOME POST PRODUCTION DAMAGES IDENTIFIED ON NAIL HOLES AND BROKEN SCREWS. THE INFORMATION ETCHED ON RETURNED ITEMS MATCH TO COMPLAINT SYSTEM AND DHR. THE NAIL LOT#8829587 HAS BEEN MANUFACTURED STARTING FROM RAW MATERIAL LOT#16636/ ART. 60010220. THE CERTIFICATE OF THE RAW MATERIAL LOT#16636 WAS REVIEWED. IN THE CERTIFICATE IT IS REPORTED THAT THE MATERIAL FULFILLS THE SPECIFICATION. THE BROKEN SCREWS LOT#9023335 AND LOT#9286948 HAVE BEEN MANUFACTURED STARTING RESPECTIVELY FROM RAW MATERIAL LOT#15975/ ART. 60010214 AND LOT#17702/ ART. 60010214. THE CERTIFICATES OF THE RAW MATERIAL LOT#15975 AND LOT#17702 WERE REVIEWED. IN THE CERTIFICATES IT IS REPORTED THAT THE MATERIAL FULFILLS THE SPECIFICATION. THE RETURNED PARTS WERE RE-INSPECTED FOR ALL THE FEATURES PERTINENT TO THE COMPLAINT CONDITION. CONSIDERING THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION AND NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED ON RETURNED ITEMS (THERE ARE SOME DAMAGES ADDRESSABLE TO POST PRODUCTION EVENTS), THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT THE RETURNED PARTS ARE CONFORMING FROM A MANUFACTURING PERSPECTIVE. MIA IS DISPOSED AS CONFIRMED DUE TO EVIDENCE THAT PART IS BROKEN, BUT IT'S CONSIDERED NOT VALID FOR (B)(4) BECAUSE THERE IS NO EVIDENCE OF ISSUES MANUFACTURING RELATED. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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. EVENT DATE: UNKNOWN.. (THERAPY DATE): UNKNOWN. INITIAL REPORTING FACILITY PHONE NUMBER IS (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: DEC 11, 2014. 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. (B)(4). 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

    THE NAIL DID NOT BREAK INTRA-OPERATIVELY. THE PATIENT REQUIRED REVISION SURGERY AND A NEW NAIL WAS IMPLANTED. NO PATIENT FURTHER PATIENT DETAILS ARE AVAILABLE. WHEN THE THEATRE STAFF REFER TO A BROKEN NAIL THEY ARE REFERRING TO THE CONSTRUCT. THE CONSTRUCT FAILED AT THE NAIL-SCREW INTERFACE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT REVISION SURGERY INCLUDING HARDWARE EXPLANT WAS PERFORMED ON (B)(6) 2017 DUE TO POSTOPERATIVE BREAKAGE OF A TIBIAL NAIL AND TWO (2) LOCKING SCREWS. THE NAIL REPORTEDLY BROKE AT AN OCCUPIED SCREW HOLE. DURING THE REVISION SURGERY THE NAIL, TWO (2) BROKEN SCREWS AND TWO (2) INTACT SCREWS WERE REMOVED. CONCOMITANT REPORTED PARTS: TWO (2)X LOCKING SCREWS (PART 04.005.428 / 9402972, PART 04.005.430 / (B)(4)). THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125152 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MEZZOVICO 9286948 07611819759923

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 04.005.428, 4.0MM TI LOCK SCREW 38MM, QTY 1| 04.005.430, 4.0MM TI LOCK SCREW 40MM, QTY 1