BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIALSCREW 60MM THREAD LENGTH

    MDR report key: 5153045 · Received October 15, 2015

    Report

    Report Number
    2530088-2015-10664
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    October 2, 2015
    Report Date
    October 2, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE SUBJECT DEVICE, PART NUMBER 04.632.760, MATRIX TI SCREW, WAS RECEIVED DIS-ASSEMBLED FROM BODY ASSEMBLY WITH THE SCREW HAVING THE M6.5X0.75-6H THREAD APPROXIMATELY 90% PEELED. THE M6.5X0.75-6H THREADS ON THE SCREW COULD NOT BE MEASURED BECAUSE OF POST MANUFACTURING DAMAGE. THE SPHERICAL OUTER DIAMETER ON THE SCREW COULD NOT BE MEASURED BECAUSE DIMENSION APPLIES AFTER ANODIZE BUT PRIOR TO BEAD BLAST. THE SPHERICAL INTERNAL DIAMETER ON COLLET COULD NOT BE MEASURED IN IT MANUFACTURED SPLIT STATE CONDITION. THE DEVICE HISTORY RECORD REVIEW (DHR), AS PREVIOUSLY REPORTED, INDICATES THAT PRODUCT WAS MANUFACTURED TO SPECIFICATION. RAW MATERIAL FOR COLLET COULD NOT BE MEASURED IN ASSEMBLED STATE, BUT WAS IDENTIFIED AS CORRECT IN DHR. FURTHER DIS-ASSEMBLY WOULD YIELD NO FURTHER DIMENSIONS BECAUSE PRODUCT FEATURES CANNOT BE MEASURED IN FINAL MANUFACTURED CONDITION. THIS COMPLAINT IS UNCONFIRMED FROM A MANUFACTURING PERSPECTIVE. A ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. THE COMPLAINT DEVICE WAS NOT IMPLANTED. 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. ADDITIONAL PRODUCT CODE: NMH, NMI, KWQ, KWP. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURE DATE: 05-06-15, PART # 04.632.760, LOT # 9805334, REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    (B)(6) REPORTED THE FOLLOWING EVENT: DURING A MATRIX LUMBAR SPINAL FUSION, AS THE SURGEON WAS INSERTING A 7X60MM MATRIX SCREW, WITH A T-RATCHET HANDLE SCREWDRIVER WITH SLEEVE, THE HEAD OF THE SCREW CAME OFF. METAL SHAVINGS OF THE SCREW WERE SALVAGED. THE SCREW WAS REMOVED AND ANOTHER SIMILAR SCREW WAS SUBSEQUENTLY INSERTED TO COMPLETE THE SURGERY. THE SURGERY WAS EXTENDED BY APPROXIMATELY 4 MINUTES DUE TO THE COMPLAINED EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684555 7.0MM TI MATRIX POLYAXIALSCREW 60MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 9805334

    Patients

    Seq Age Sex Outcome Treatment
    1