BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC* PATELLAR CEMENTING CLAMP

    MDR report key: 12933367 · Received December 6, 2021

    Report

    Report Number
    1818910-2021-27166
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Report Date
    November 23, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HXD
    UDI-DI
    10603295216605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE WITHOUT THE DEVICE TO EXAMINE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ORANGE RUBBER RING ON THE CLAMPING MECHANISM OF A PFC SIGMA PATELLAR CLAMP. SOME OF THE RUBBER APPEARS TO HAVE BEEN WORN AWAY. IT ISN¿T POSSIBLE TO SPECIFY HOW AND WHEN THIS OCCURRED.

    Description of Event or Problem · 0

    I WAS PRESENTED WITH THE DAMAGED DECONTAMINATED INSTRUMENT OUTSIDE OF THEATRE. IT¿S ASSUMED THAT IT HAD BEEN IN USE FOR SOME TIME AND NOT POSSIBLE TO DETERMINE WHEN AND HOW THE DAMAGE OCCURRED. I WASN¿T INFORMED THAT IT HAD CAUSED ANY SURGICAL DELAY WHEN IT WAS LAST USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830123 PFC* PATELLAR CEMENTING CLAMP KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS HXD DEPUY ORTHOPAEDICS INC US 86-5035 H0501 10603295216605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown