BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR 2.7 HEAD 2.4 SELF-TAP L10 TA

    MDR report key: 7120899 · Received December 15, 2017

    Report

    Report Number
    8030965-2017-50728
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 16, 2017
    Report Date
    November 16, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819425194
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE'S DEVICE HISTORY RECORD SHOWED THAT THE LOT WAS RELEASED AFTER COMPLETE FINAL INSPECTION WITH NO DETECTED ISSUES REGARDING MANUFACTURING PROCEDURE. DURING INVESTIGATION, THE COMPLAINT CONDITION WAS CONFIRMED. MICROSCOPIC INVESTIGATION SHOWS THAT THE LOCKING THREAD IS BADLY DAMAGED. THE THREAD EXPERIENCED PLASTIC DEFORMATION WHICH WOULD NOT ALLOW LOCKING THE SCREW HEAD IN THE PLATE. ADDITIONALLY, THE THREAD AT THE SCREW SHAFT IS DEFORMED. THIS LED TO A CONCLUSION THAT THE SCREW WAS NOT PROPERLY ALIGNED DURING INSERTION, AS RESULT; THE THREAD CAME INTO HARD CONTACT WITH THE PLATE WHAT FINALLY CAUSED THE REPORTED DAMAGE OF THE THREADS. FURTHERMORE, PLASTIC DEFORMATION WAS IDENTIFIED AT THE STAR-DRIVE RECESS, INDICATING EXCESSIVE APPLICATION OF MECHANICAL FORCE DURING INSERTION. DUE TO THE DEFORMATION / DAMAGE, IT WAS NOT POSSIBLE TO MEASURE THE DIMENSION / SHAPE OF THE LOCKING THREADS. THIS IS BEING CLASSIFIED AS A HANDLING ERROR WHILE INSERTION. A MANUFACTURING ISSUE CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW: THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 14.FEB.2017. EXPIRY DATE: 01.FEB.2027. 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. NON-STERILE 04.211.010 / H231750 WAS MANUFACTURED IN US. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 23-JAN-2017. PART NO: 04.211.010 (EU ITEM), LOT NO: H231750 (NON-STERILE) - 2.7MM TI VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM. QUANTITY (B)(4). COMPONENTS REVIEWED: (B)(4) MATERIAL PART 04.211.010.999, 2.8MM TI SCREW BLANK 10MM. BP55, LOT 7995294 MEET SPECIFICATION. (B)(4) MATERIAL WAS RELEASED TO (B)(4) ON 24-APR-2015. INSPECTION SHEET FOR MILL SHAFT THREADS/HEAD THREAD/FLUTE FINAL INSPECTION MEETS INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS 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

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. (B)(4). IMPLANT DATE IS UNKNOWN. EXPLANT DATE IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. TELEPHONE NUMBER UNKNOWN. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DEVICES WERE USED IN THE SURGERY FOR THE FRACTURE OF THE PELVIC DORSAL WALL ON (B)(6) 2017. ALTHOUGH THE REPORTED DEVICES WERE SUPPOSED TO BE FOR THE FOOT OPERATION, BY THE SURGEON¿S JUDGEMENT, THESE DEVICES WERE USED TO THE PELVIS THIS TIME. WHILE THE SURGEON WAS INSERTING THE LOCKING SCREW IN QUESTION (04.211.010S, 04.211.010S, OR 04.211.014S) TO THE PLATE IN QUESTION (04.211.203S), IT WAS FOUND THAT THE LOCKING SCREW IN QUESTION HAD PENETRATED THROUGH THE PLATE HOLE. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. ALL THE SCREWS WERE REMOVED OUT OF THE INITIAL INCISION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899422 VA LOCKSCR 2.7 HEAD 2.4 SELF-TAP L10 TA SCREW,FIXATION,BONE HWC OBERDORF : SYNTHES PRODUKTIONS GMBH L304255 07611819425194

    Patients

    Seq Age Sex Outcome Treatment
    1