BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5047355 · Received September 1, 2015

    Report

    Report Number
    1000562954-2015-10175
    Event Type
    Injury
    Date Received
    September 1, 2015
    Report Date
    August 27, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS (B)(6). THE FOLLOWING SCREWS WERE RECEIVED FOR THIS COMPLAINT; HOWEVER, IT IS NOT KNOWN WHICH DEVICE BACKED OUT: PART NUMBER 214.836 / LOT NUMBER 9017087 4.5MM CORTEX SCREW SELF-TAPPING 36MM 510 (K) K112583. DEVICE PRODUCT CODE: HWC. COMMON NAME: SCREW, FIXATION BONE. PART NUMBER 212.209 / LOT NUMBER 8989651 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 30MM 510(K) K000682 DEVICE PRODUCT CODE: KTT. COMMON NAME: APPLIANCE,FIXATION,NAIL ADDITIONAL DEVICE PRODUCT CODES ARE HRS AND HWC. PART NUMBER 212.209 / LOT NUMBER 9193483 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 30MM 510(K) K000682 DEVICE PRODUCT CODE: KTT. COMMON NAME: APPLIANCE,FIXATION,NAIL ADDITIONAL DEVICE PRODUCT CODES ARE HRS AND HWC. PART NUMBER 212.209 / LOT NUMBER 9261354 / 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 30MM 510(K) K000682 DEVICE PRODUCT CODE: KTT. COMMON NAME: APPLIANCE,FIXATION,NAIL ADDITIONAL DEVICE PRODUCT CODES ARE HRS AND HWC. (B)(6). NOT KNOWN WHICH OF THE RECEIVED SCREWS BACKED OUT THE DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED FOR THE FOLLOWING: MANUFACTURING LOCATION: (B)(4), ART. NO.: 214.836 LOT NO 9017087 MANUFACTURING DATE: 28. JUL 2014, ART. NO.: 212.209 LOT NO 8989651 MANUFACTURING DATE: 21. MAY 2014, ART. NO.: 212.209 LOT NO 9193483 MANUFACTURING DATE: 08. OCT 2014, ART. NO.: 212.209 LOT NO 9261354 MANUFACTURING DATE: 01. DEC 2014, 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. A PRODUCT INVESTIGATION WAS ATTEMPTED. FOUR INTACT SCREWS WERE RECEIVED AS DESCRIBED ABOVE. SINCE THE PART AND LOT NUMBER OF THE SUBJECT DEVICE ARE NOT KNOWN, THE DEVICE CANNOT BE FULLY ANALYZED AND INVESTIGATED. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015. THE PATIENT WAS EXPERIENCING PAIN AFTER THE INITIAL SURGERY (ON (B)(6) 2015), SO THE SURGEON DECIDED TO PERFORM A REVISION. DURING THE REVISION, IT WAS DISCOVERED THAT ONE SCREW HAD BROKEN AND ONE HAD BACKED OUT. THE SURGEON REMOVED THE TWO MALFUNCTIONING SCREWS AND PLACED TWO NEW SCREWS ON THE PATIENT'S FRACTURE. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 27, 2015, REPORTING THAT RETURNED PARTS FROM COMPLAINT NUMBERS (B)(4) AND (B)(4) WERE INADVERTENTLY MIXED BY SENDER. THREE INTACT LOCKING SCREWS AND ONE INTACT CORTEX SCREW WERE RECEIVED FOR THIS COMPLAINT; HOWEVER, IT IS UNKNOWN WHICH OF THESE SCREWS IS THE ONE THAT BACKED OUT POSTOPERATIVELY. THIS EVENT WAS PREVIOUSLY REPORTED BUT UNDER A SEPARATE REPORT FOR THIS COMPLAINT. THIS REPORT IS FOR ONE, UNKNOWN CANNULATED LOCKING SCREW. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577021 SCREW, FIXATION, BONE HWC SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention