BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6288394 · Received January 30, 2017

    Report

    Report Number
    3009450884-2017-10007
    Event Type
    Injury
    Date Received
    January 30, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 10, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    K150099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: UNKNOWN IF EXPLANTED. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: NO MATERIAL WAS RETURNED FOR INVESTIGATION. COMPLAINED ISSUE (SCREW BREAKAGE) COULD NOT BE CONFIRMED. REVIEW OF THE X-RAYS SHOWED NO CLEAR EVIDENCE THAT THE DRILL IS BROKEN. COMPLAINT DETERMINED AS UNCONFIRMED BASED ON AVAILABLE INFORMATION. ROOT CAUSE COULD NOT BE DEFINED DUE THE MISSING MATERIAL. NO MANUFACTURING RELATED FAILURE WAS FOUND. 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. AN EVENT DATE OF (B)(6) 2017 WAS REPORTED BUT IT IS UNCLEAR IF THIS IS THE DATE THE BROKEN SCREW WAS DISCOVERED OR IF IT WAS INDEED THE DATE THE SCREW BROKE. ADDITIONAL DEVICE PRODUCT CODE IS HWC. THIS REPORT IS FOR ONE UNKNOWN SCREW. THE PART AND LOT NUMBER OF THE BROKEN SCREW COULD NOT BE IDENTIFIED VIA X-RAY. OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE FOLLOWING SCREWS WERE IMPLANTED IN THE PATIENT: PART NUMBER 04.130.012S, LOT NUMBER 9847058, 1.3MM TI CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM, 510(K) K150099, COMMON NAME ¿ PLATE, FIXATION, BONE, DEVICE PRODUCT CODES- HRS AND HWC, QTY 1; PART NUMBER 04.130.014S, LOT NUMBER 9837884, 1.3MM TI CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 14MM, 510(K) K150099, COMMON NAME ¿ PLATE, FIXATION, BONE, DEVICE PRODUCT CODES- HRS AND HWC, QTY 2; ART NUMBER 04.130.106S, LOT NUMBER 9888940, 1.3MM TI LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 6MM, 510(K) K150099, COMMON NAME ¿ PLATE, FIXATION, BONE, DEVICE PRODUCT CODES- HRS AND HWC, QTY 1; PART NUMBER 04.130.112S, LOT NUMBER 9942533, 1.3MM TI LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM, 510(K) K150099, COMMON NAME ¿ PLATE, FIXATION, BONE, DEVICE PRODUCT CODES- HRS AND HWC, QTY 1; PART NUMBER 04.130.114S, LOT NUMBER 9837815, 1.3MM TI LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 14MM, 510(K) K150099, COMMON NAME ¿ PLATE, FIXATION, BONE, DEVICE PRODUCT CODES- HRS AND HWC, QTY 1. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEWS WERE PERFORMED FOR THE IMPLANT SCREW LOT NUMBERS. THE RESULTS ARE AS FOLLOWS: ALL LOTS MANUFACTURING LOCATION: (B)(4), 04.130.012S / 9847058-MANUFACTURING DATE: 14.MAR.2016 EXPIRY DATE: 01.MAR.2026; 04.130.014S / 9837884-MANUFACTURING DATE: 03.MAR.2016 EXPIRY DATE: 01.FEB.2026; 04.130.106S / 9888940-MANUFACTURING DATE: 07.APR.2016 EXPIRY DATE: 01.MAR.2026; 04.130.112S / 9942533-MANUFACTURING DATE: 18.MAY.2016 EXPIRY DATE: 01.MAY.2026; 04.130.114S / 9837815-MANUFACTURING DATE: 03.MAR.2016 EXPIRY DATE: 01.FEB.2026. ALL LOTS REVIEWED-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. (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

    IMPLANTED SCREWS (IT IS UNKNOWN WHICH SCREW BROKE AND WHICH ARE CONCOMITANT): CORTEX SCREW 12MM, (PART 04.130.012S, LOT 9847058, QUANTITY 1); CORTEX SCREW 14MM, (PART 04.130.014S, LOT 9837884, QUANTITY 2); LOCKING SCREW 6MM, (PART 04.130.106S, LOT 9888940, QUANTITY 1); LOCKING SCREW 12MM, (PART 04.130.112S, LOT 9942533, QUANTITY 1); LOCKING SCREW 14MM, (PART 04.130.114S, LOT 9837815, QUANTITY 1).

    Description of Event or Problem · 1

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER INITIAL IMPLANT SURGERY TO TREAT AN INDEX FINGER PROXIMAL PHALANX FRACTURE ON (B)(6) 2016, X-RAY REVEALED THAT ONE OF THE SCREWS HAD BROKEN. THE PATIENT WAS IMPLANTED WITH A LOCKING Y-PLATE AND SIX (6) SCREWS. IT IS NOT KNOWN WHICH SCREW PART NUMBER HAD BROKEN. THE PATIENT IS CURRENTLY STABLE. CONCOMITANT MEDICAL PRODUCTS: 1X 04.130.153S / LOT UNK (LOCKING Y-PLATE 1.3 HE 3HO SHAFT 5HO L27). THIS REPORT IS FOR ONE UNKNOWN SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70775 PLATE, FIXATION, BONE HRS SYNTHES GRENCHEN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention 04.130.153S, 1.3MM TI LCKNG Y-PLATE 3H HEAD/5H SHA