BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMATOME AN HANDPIECE

    MDR report key: 10282819 · Received July 16, 2020

    Report

    Report Number
    0001526350-2020-00613
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Report Date
    January 7, 2021
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. D4: THREE DEVICES WERE REPORTED TO US ON THIS COMPLAINT, THOUGH IT IS UNABLE TO BE DETERMINED WHICH EXACT DEVICE WAS EXHIBITING THE REPORTABLE MALFUNCTION OF HARVESTING SKIN THICKER THAN DESIRED. ITEM#: 88710100; LOT#: 64324677; SERIAL#: (B)(6). MANUFACTURE DATE: 14-FEB-2019. STERILE EXPIRY DATE: UNK. UDI: (B)(4). FDA CLASS CODE: I; 510K: EXEMPT; FDA PRODUCT CODE: GFD; MDL #: C041134. QTY: 1. OR ITEM#: 88710100; LOT#: 64367743; SERIAL#: (B)(6). MANUFACTURE DATE: 22-MAR-2019. STERILE EXPIRY DATE: UNK. UDI: (B)(4). FDA CLASS CODE: I; 510K: EXEMPT; FDA PRODUCT CODE: GFD; MDL #: C041134. QTY: 1. OR ITEM#: 00-8851-002-06, LOT#: 64454759, SERIAL#: (B)(6). MANUFACTURE DATE: 9-JULY-2019. STERILE EXPIRY DATE: UNK. UDI: (B)(4). FDA CLASS CODE: I; 510K: EXEMPT; FDA PRODUCT CODE: GFD; MDL #: C041134. QTY: 1. SN (B)(6): REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE UNIT WAS OUT OF CALIBRATION AND THE CONTROL BAR WAS NOT IN THE CORRECT POSITION. THE UNIT WAS RECALIBRATED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE EVENT IS CONFIRMED. SN (B)(6): REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE UNIT WAS OUT OF CALIBRATION AND THE CONTROL BAR WAS NOT IN THE CORRECT POSITION. THE CONTROL BAR WAS REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE EVENT IS CONFIRMED. SN (B)(6): NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. THE EVENT CANNOT BE CONFIRMED. ALL SN'S: DEVICE(S) IS/ARE USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER CMP-(B)(4). ONCE AN INVESTIGATION OF THIS DEVICE IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED. THREE DEVICES WERE REPORTED TO US ON THIS COMPLAINT, THOUGH IT IS UNKNOWN WHICH EXACT DEVICE WAS EXHIBITING THE REPORTABLE MALFUNCTION OF HARVESTING SKIN THICKER THAN DESIRED. TO MAKE UP FOR THIS, ALL THREE DEVICES WILL BE LISTED BELOW, AND A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED TO CLARIFY PRECISELY WHICH DEVICE WAS HARVESTING SKIN EXCESSIVELY. ITEM#: 88710100; LOT#: 64324677; SERIAL#: (B)(4), MANUFACTURE DATE: UNK, STERILE EXPIRY DATE: UNK, UDI: UNK, FDA CLASS CODE: I; 510K: EXEMPT; FDA PRODUCT CODE: GFD; MDL #: C041134 QTY: 1. OR ITEM#: 88710100; LOT#: 64367743; SERIAL#: (B)(4), MANUFACTURE DATE: UNK, STERILE EXPIRY DATE: UNK, UDI: UNK, FDA CLASS CODE: I; 510K: EXEMPT; FDA PRODUCT CODE: GFD; MDL #: C041134 QTY: 1. OR ITEM#: 00-8851-002-06, LOT#: 64454759, SERIAL#: (B)(4), MANUFACTURE DATE: UNK, STERILE EXPIRY DATE: UNK, UDI: UNK, FDA CLASS CODE: I; 510K: EXEMPT; FDA PRODUCT CODE: GFD; MDL #: C041134, QTY: 1. (B)(6). DR. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY CHECKED THE MACHINE AND FOUND OUT THAT THE MOTOR WAS STUCK AND THE MOTOR CONTROLLER WAS BURNT (SHORTED) DUE TO THE MOISTURE AND WET MOTOR CONTROLLER. ADDITIONAL INFORMATION WAS LATER ACQUIRED THAT DURING SURGERY, A DERMATOME WAS VERY NOISY. ANOTHER DEVICE WAS FOUND, WHICH WAS ALSO FOUND TO BE TOO NOISY. IT WAS ALSO REPORTED THAT ONE OF THESE DEVICE WAS HARVESTING SKIN THICKER THAN DESIRED, HOWEVER IT IS UNKNOWN BY THE CUSTOMER WHICH OF THE DEVICES BEING RETURNED WAS BEHAVING THIS WAY. THERE WAS A 15-30 MINUTE DELAY. THE EVENT OCCURRED IN APRIL 2020, BUT AN EXACT DATE IS NOT KNOWN. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749767 DERMATOME AN HANDPIECE DERMATOME GFD ZIMMER SURGICAL, INC. N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1