BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5343571 · Received January 5, 2016

    Report

    Report Number
    2520274-2016-10039
    Event Type
    Injury
    Date Received
    January 5, 2016
    Report Date
    December 14, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF POSTOPERATIVE SCREW BREAKAGE IS UNKNOWN. THE PART AND LOT NUMBERS FOR THE IMPLANTED SCREWS HAVE BEEN PROVIDED AND ARE LISTED BELOW WITH THE APPLICABLE DETAILS. IT IS UNKNOWN, HOWEVER, HOW MANY (AND WHICH OF THESE) SCREWS ACTUALLY BROKE. PART 02.207.105S / LOT 8357137: 7.3MM CANNULATED LOCKING SCREW 105MM ¿ JDW: PIN, FIXATION, THREADED ¿ K040765. PART 02.207.105S / LOT 8125849: 7.3MM CANNULATED LOCKING SCREW 105MM ¿ JDW: PIN, FIXATION, THREADED ¿ K040765. PART 213.340S / LOT 8420952: 5.0MM LOCKING SCREW SELF-TAPPING 40MM ¿ KTT: APPLIANCE, FIXATION, NAIL; HWC: SCREW, FIXATION, BONE ¿ K000682. PART 213.342S / LOT 8322946: 5.0MM LOCKING SCREW SELF-TAPPING 42MM ¿ KTT: APPLIANCE, FIXATION, NAIL; HWC: SCREW, FIXATION, BONE ¿ K000682. PART 213.342S / LOT 8630286: 5.0MM LOCKING SCREW SELF-TAPPING 42MM ¿ KTT: APPLIANCE, FIXATION, NAIL; HWC: SCREW, FIXATION, BONE ¿ K000682. PART 213.344S / LOT 8630098: 5.0MM LOCKING SCREW SELF-TAPPING 44MM ¿ KTT: APPLIANCE, FIXATION, NAIL; HWC: SCREW, FIXATION, BONE ¿ K000682. PART 214.838S / LOT 7690200: 4.5MM CORTEX SCREW SELF-TAPPING 38MM ¿ HWC: SCREW, FIXATION, BONE ¿ K112583. PART 214.840S / LOT 8465664: 4.5MM CORTEX SCREW SELF-TAPPING 40MM ¿ HWC: SCREW, FIXATION, BONE ¿ K112583. WITHOUT VERIFICATION OF EXACTLY WHICH SCREWS BROKE, THE AFFECTED UDI(S) CANNOT BE DETERMINED. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DHRS FOR EACH OF THE POTENTIAL PART/LOT COMBINATIONS WAS CONDUCTED WITH RESULTS AS FOLLOWS: PART 02.207.105S / LOT 8357137 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: APRIL 18, 2013 - EXPIRY DATE: APRIL 1, 2023. PART 02.207.105S / LOT 8125849 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 25, 2012 - EXPIRY DATE: OCTOBER 1, 2022. PART 213.340S / LOT 8420952 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: MAY 14, 2013 - EXPIRY DATE: MAY 1, 2023. PART 213.342S / LOT 8322946 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: MARCH 11, 2013 - EXPIRY DATE: MARCH 1, 2023. PART 213.342S / LOT 8630286 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 4, 2013 - EXPIRY DATE: SEPTEMBER 1, 2023. PART 213.344S / LOT 8630098 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 1, 2013 - EXPIRY DATE: SEPTEMBER 1, 2023. PART 214.838S / LOT 7690200 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: DECEMBER 14, 2011 - EXPIRY DATE: DECEMBER 1, 2021. PART 214.840S / LOT 8465664 - MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JUNE 17, 2013 - EXPIRY DATE: JUNE 1, 2023. NO NON-CONFORMANCE REPORTS (NCR) WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE 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 A PATIENT PRESENTED WITH HIP PAIN AT A CLINICAL FOLLOW UP APPOINTMENT IN (B)(6) 2015. PER THE PATIENT, THE PAIN BEGAN APPROXIMATELY TWENTY (20) DAYS PRIOR TO THE APPOINTMENT DATE. AN X-RAY IMAGE TAKEN DURING THE VISIT DETECTED THAT THE PROXIMAL SCREWS OF THE 4.5MM PROXIMAL FEMUR LOCKING COMPRESSION PLATE (LCP) HAD RUPTURED (BROKEN). THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2015 TO HAVE THE ORIGINAL HARDWARE REMOVED. ALL PIECES OF THE BROKEN SCREWS WERE SUCCESSFULLY RETRIEVED. NEW HOMOLOGOUS BONE IMPLANTS WERE THEN USED AS THERE WAS NO EVIDENCE OF PSEUDOARTHROSIS HEALING. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF SURGICAL DELAY. THE PATIENT'S POSTOPERATIVE STATUS WAS LISTED AS "OK". THIS REPORT IS FOR AN UNKNOWN NUMBER OF BROKEN SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5340 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 242.806S: 4.5MM PROXIMAL FEMUR LCP 6H/211MM/RIGHT