BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR Ø5 SELF-TAP L75 SST

    MDR report key: 6615015 · Received June 6, 2017

    Report

    Report Number
    9612488-2017-10243
    Event Type
    Injury
    Date Received
    June 6, 2017
    Report Date
    May 9, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    UDI-DI
    07611819240216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (LOCKSCR Ø5 SELF-TAP L75 SST, PART NUMBER 213.375, LOT NUMBER 9041822). THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER: 213.375 ¿ 9041822 / LOCKSCR Ø5 SELF-TAP L75 SST: UPON VISUAL INSPECTION, THE HEAD THREAD AT THE RECEIVED SCREW IS BADLY DAMAGED/DEFORMED AND THE SHANK HAS ALSO SOME SCRATCHES/DEFORMATION. OTHERWISE THE ARTICLE IS IN GOOD CONDITION. AS PART OF THE CHU INVESTIGATION WE HAVE MEASURED THE NECK DIAMETER Ø4.40 +/-0.10, AND THE LENGTH 75.00 +0.70/0 WITH THE CALIPER 3-01-17584, THE RESULT (Ø4.44 / 75.16) MEET THE SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE AFFECTED ARTICLE AND LOT COMBINATIONS, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. NO NCRS WERE MARKED IN THE DHR DURING PRODUCTION. MOREOVER, A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS, THAT THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE FROM THESE ARTICLE AND LOT COMBINATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED TO THIS, NO FURTHER INVESTIGATION WILL BE DONE, AS RAW MATERIAL AND FUNCTIONAL. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE. 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

    REMOVE CONCOMITANT PART: PEDIATRIC LCP CONDYLAR PLATE (PART # 02.108.420, LOT # L270351, QUANTITY 1) FROM PREVIOUS MW. THIS CONCOMITANT PART IS NOW PART OF THE PART DATA. 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¿S DATE OF BIRTH AND WEIGHT ARE UNKNOWN. DATE OF POSTOPERATIVE SCREW BACK OUT IS UNKNOWN. (B)(4). (B)(6). CODE (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART: 213.375, LOT: 9041822: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24.JUL.2014: NO NON CONFORMANCE REPORTS (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. HE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 INDIA AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH PEDIATRIC LOCKING FEMUR PLATE AND UNKNOWN NUMBER OF SCREWS ON APR 19, 2017. FEW DAYS AFTER THE SURGERY, THE SURGEON FOUND THAT THE THREE (3) OF THE LOCKING SCREWS CAME OUT OF THE LOCKING HOLES. THE SURGEON EXPLANTED THE PLATE AND SCREWS ON (B)(6) 2017. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND ANY OTHER MEDICAL INTERVENTION REQUIRED. PATIENT OUTCOME REPORTED AS OKAY. CONCOMITANT PART: PEDIATRIC LCP CONDYLAR PLATE (PART # 02.108.420, LOT # L270351, QUANTITY 1) THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW SELF-TAPPING. THIS IS REPORT 2 OF 3 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395740 LOCKSCR Ø5 SELF-TAP L75 SST APPLIANCE,FIXATION,NAIL KTT SYNTHES BETTLACH 9041822 07611819240216

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention PLATE (PART # 02.108.420, LOT # L270351, QTY 1)