BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5 X 4 MM LACTOSORB SCREW

    MDR report key: 7598048 · Received June 13, 2018

    Report

    Report Number
    0001032347-2018-00359
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    March 29, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    NHB
    PMA / PMN Number
    PK012409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE LACTOSORB SCREW 1.5X4MM 1.5 SYSTEM 2PK (PART# 915-2315, LOT# 481170) COULD NOT BE VISUALLY EVALUATED OR FUNCTIONALLY TESTED BECAUSE THE PARTS WERE NOT RETURNED AND NO PHOTOS WERE PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT HAS THE FOLLOWING INFORMATION IN THE SECTION TITLED WARNINGS: IMPROPER SELECTION, PLACEMENT, POSITIONING, OR FIXATION OF THE IMPLANT CAN CAUSE A SUBSEQUENT UNDESIRABLE RESULT. DEVICES SHOULD NOT BE LOCATED DIRECTLY UNDER A SUTURE SITE. THE SURGEON IS TO BE FAMILIAR WITH THE DEVICES, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY. THE IFU ALSO HAS THE FOLLOWING INFORMATION FOR WHICH THE PRODUCT SHOULD NOT BE USED UNDER THE SECTION TITLED CONTRAINDICATIONS: PATIENT CONDITIONS INCLUDING, BLOOD SUPPLY LIMITATIONS, INSUFFICIENT QUANTITY OR QUALITY OF BONE STOCK OR LATENT INFECTION. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. DEVICE EVALUATED BY MANUFACTURER AND NOT RETURNED TO MANUFACTURER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00360-1.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION 1.5 MM SELF-DRILLING LACTOSORB TAP, DENSE BONE CATALOG #: 915-1590-01 LOT #: NI, BIOMET MICROFIXATION BATTERY POWERED POWER DRIVER CATALOG #: 50-1000 LOT #: NI, BIOMET MICROFIXATION 1.5 MM SYSTEM POWER DRIVER BATTERY CATALOG #: 50-1010 LOT #: 723700. CONCOMITANT MEDICAL PRODUCTS THERAPY DATE: (B)(6) 2018. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00360.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON USED THE DENSE BONE TAP, INSERTED SIX SCREWS, AND THEN FINISHED USING THE HEAT PEN. HOWEVER, ALL SIX SCREWS HAVE COME OFF THE BONE. THE CUSTOMER BELIEVES THE INCIDENT WAS CAUSED BY THE BONE TAP. THERE WAS A TWENTY MINUTE DELAY. THE PATIENT DID NOT RETAIN A FOREIGN BODY AND THE SURGERY WAS COMPLETED USING ANOTHER DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440599 1.5 X 4 MM LACTOSORB SCREW BONE SCREW NHB BIOMET MICROFIXATION N/A 481170

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR