BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI NARROW LCP® PLATE 8 HOLES/152MM

    MDR report key: 6906067 · Received September 29, 2017

    Report

    Report Number
    3009450884-2017-10139
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    September 9, 2017
    Report Date
    September 12, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HWC, KTT. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 28.NOV.2016 EXPIRY DATE: 01.NOV.2026. 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. 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 RETURNED TO MANUFACTURER. A PRODUCT MANUFACTURING INVESTIGATION WAS PERFORMED. ONE (1) LCP 4.5/5 NARROW 8HO L152 TI (PART # 424.581S, LOT # L184948) RECEIVED AND FORWARDED TO MANUFACTURING PLANT FOR INVESTIGATION. THE PLATE IS BROKEN AT HOLE 5 (COUNTED FROM LEFT SIDE). IT HAS SEVERAL SCRATCHES, SEVERAL ABRASIONS AND INJURIES ON THE SURFACE AND WITHIN HOLES. THE LASER MARKING IS READABLE AND THE PLATE WAS RETURNED IN PACKAGING DIFFERENT FROM THE ORIGINAL ONE. A DHR REVIEW WAS PERFORMED FOR THE AFFECTED LOT L184948 / (B)(4) / ARTICLE 424.581S WHICH INCLUDES THE FINISH GOOD PRODUCT AND ITS COMPONENTS. THE INITIAL AND FINAL LOT SIZE WAS 12 PIECES; THERE WAS NO SCRAP. NO ABNORMALITIES OR DEVIATIONS WERE DETECTED. NON-CONFORMANCE (NC) WAS TRIGGERED RELATING TO THE FIRE INCIDENT IN SCREWS DEPARTMENT ON 06 OCTOBER 2016 BUT THIS COULD NOT LEAD TO THE COMPLAINT FAILURE. ALL DIMENSIONS OF THE RECEIVED FRAGMENT OF THE PLATE RELEVANT FOR THE COMPLAINT CONDITION WERE MEASURED, AND FULFILL THE SPECIFICATIONS. THE THICKNESS MEASUREMENT WAS PERFORMED CLOSE TO THE BREAKAGE. THE RAW MATERIAL CERTIFICATES WERE CHECKED AND IT WAS FOUND THAT ALL USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. DIMENSIONS OF THE PLATE AS WELL AS ITS MANUFACTURING DOCUMENTATION WERE CHECKED AND IT WAS MANUFACTURED ACCORDING SPECIFICATIONS AS MENTIONED BEFORE. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED BECAUSE THE PLATE IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, THIS COMPLAINT IS RATED NOT VALID FROM THE MANUFACTURING POINT OF VIEW SINCE NO DEVIATIONS WERE FOUND IN THE MANUFACTURING DOCUMENTATION AS WELL AS DURING THE INVESTIGATION ALL RELEVANT MEASUREMENTS PERFORMED ACCORDING TO THE DRAWING HAVE PASSED THE SPECIFICATIONS. EXACT ROOT CAUSE FOR THIS PLATE BREAKAGE COULD NOT BE FOUND. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. CONCOMITANT PARTS: BELOW LISTED SCREWS WERE RATED AS CONCOMITANT, AND ARE IN A GOOD CONDITION AND THEREFORE NO INVESTIGATION WAS PROVIDED: 1X 413.334S / L261634 (LOCKSCR Ø5 SELF-TAP L34 TAN) , 2X 413.336S / L267187 (LOCKSCR Ø5 SELF-TAP L36 TAN) , 1X 413.338S / 9946069 (LOCKSCR Ø5 SELF-TAP L38 TAN) , 1X 413.338S / L252453 (LOCKSCR Ø5 SELF-TAP L38 TAN) , 1X 413.338S / L283483 (LOCKSCR Ø5 SELF-TAP L38 TAN) , 1X 413.338S / L259889 (LOCKSCR Ø5 SELF-TAP L38 TAN) , 1X 414.032S / 2783019 (CORTEX SCREW Ø 4.5MM, L 32MM). LOT NUMBER FOR PART 414.032S CORRECTED. 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 PATIENT OBTAINED A TIBIAL AND FIBULAR STRESS FRACTURE. ON (B)(6) 2017, THE FIXATION SURGERY PLACEMENT FOR THE TIBIAL FRACTURE AND THE KIRSCHNER WIRE (K-WIRE) PLACEMENT FOR THE FIBULAR FRACTURE WERE PERFORMED IN ANOTHER HOSPITAL. ON (B)(6) 2017, K-WIRE WHICH HAD BEEN INSERTED IN THE FIBULA WAS REMOVED, ALSO AT THE OTHER HOSPITAL. THIS WAS A PLANNED REMOVAL SURGERY. ON (B)(6) 2017, THE NARROW PLATE SEEMED TO BE BROKEN WHILE THE PATIENT WAS WALKING. ON (B)(6) 2017, THE NARROW PLATE WAS REMOVED. AT THE SAME TIME A RE-FIXATION SURGERY INVOLVING THE EXPERT TIBIAL NAIL FOR THE TIBIAL FRACTURE AND THE K-WIRE PLACEMENT FOR THE FIBULAR FRACTURE WAS ALSO PERFORMED. THE PATIENT HAS BEEN ON REHABILITATION THERAPY WITH MEDICAL FOLLOW-UP. CONCOMITANT DEVICES REPORTED: 5.0MM LOCKING HEAD SCREW 34MM (413.334S, LOT L261634, QUANTITY 1), 5.0MM LOCKING HEAD SCREW 36MM (413.336S, LOT L267187, QUANTITY 2), 5.0MM LOCKING HEAD SCREW 38MM (413.338S, LOT 9946069, QUANTITY 1), 5.0MM LOCKING HEAD SCREW 38MM (413.338S, LOT L252453, QUANTITY 1), 5.0MM LOCKING HEAD SCREW 38MM (413.338S, LOT L283483, QUANTITY 1), 5.0MM LOCKING HEAD SCREW 38MM (413.338S, LOT L259889, QUANTITY 1), 4.5MM CORTEX SCREW 32MM (414.032S, LOT 7612967, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM NARROW LCP PLATE 8 HOLE 152MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICE REPORTED: 4.5MM TI CORTEX SCREW 32MM (414.032S, LOT 2783019, QUANTITY 1)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685539 4.5MM TI NARROW LCP® PLATE 8 HOLES/152MM PLATE,FIXATION,BONE HRS SYNTHES GRENCHEN L184948

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention