BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM TITANIUM SCREW ANCHOR WITH NEEDLES

    MDR report key: 6017696 · Received October 11, 2016

    Report

    Report Number
    0001825034-2016-04074
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 12, 2016
    Report Date
    April 5, 2017
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HWC
    PMA / PMN Number
    PK080088
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 902581, 5.0 ALLTHREAD TI 2#2 MB TPRD N, LOT # 932310. THE LABELING AND PACKAGING WAS RECEIVED FOR EVALUATION. IT WAS FOUND THAT THE OUTER BOX AND PATIENT LABELS READ PN 902571, LN 068080. ADDITIONALLY, THE SHRINK WRAP THAT ALLEGEDLY WAS ON THE BOX WAS RETURNED AND THE STICKER ALSO SAYS PN 902571, LN 068080. HOWEVER, THE LABEL ON THE SEALED TYVEK POUCH OF THE PRODUCT READS PN 902581, LN 932310. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES PN 902571, LN 068080 WAS LABELED 6 MONTES EARLIER THAN PN 902581, LN 932310 WAS. THIS INDICATES THAT THE TWO ORDERS WERE NOT ON THE SAME LINE AT THE SAME TIME, AS WELL AS THERE IS NO INDICATION THAT EITHER ORDER WAS REWORKED OR REPACKED. THERE HAVE BEEN NO COMPLAINTS AGAINST EITHER LOT. IT CANNOT BE CONFIRMED THAT THE PRODUCT WAS RECEIVED AS A COMINGLED PRODUCT. THE COMPLAINT IS THEREFORE NON-VERIFIABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR BOTH LOT NUMBERS IN QUESTION AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED FOR EITHER. THIS DEVICE IS USED FOR TREATMENT. THE COMPLAINT HISTORY REVIEW WAS CONDUCTED FOR THE DEVICES AND FOUND NO ADDITIONAL COMPLAINTS FOR THE SAME LOTS FOR BOTH IN QUESTION. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PRODUCT INSIDE OF THE PACKAGE DID NOT MATCH THE LABEL ON THE PACKAGE. ANOTHER PRODUCT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT INJURY OR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667605 5.0MM TITANIUM SCREW ANCHOR WITH NEEDLES FIXATION, SCREW HWC BIOMET SPORTS MEDICINE N/A 068080

    Patients

    Seq Age Sex Outcome Treatment
    1