BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 HOLE DOUBLE COMPRESSION PLATE

    MDR report key: 5650047 · Received May 12, 2016

    Report

    Report Number
    1220246-2016-00218
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    April 18, 2016
    Report Date
    June 24, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K130510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE NON-COMPLIANCE TO THE POST-OP PROTOCOL OR POST-OP TRAUMA TO THE SURGICAL SITE. PER DEVICE DIRECTIONS FOR USE (DFU-0192), UNTIL BONE HEALING IS COMPLETE, FIXATION GIVEN WITH THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. COMPLAINT CONFIRMED. THE DEVICE MET ALL MATERIAL SPECIFICATION AS RECEIVED. THE EVALUATION REVEALED THE RETURNED COMPRESSION PLATE IS BROKEN IN HALF INDICATING THAT THIS IS A CYCLIC FATIGUE RELATED FAILURE WHICH OCCURRED ADJACENT TO THE OSTEOTOMY CUT SITE. THE MOST LIKELY CAUSE(S) FOR THE COMPLAINANT'S EVENT INCLUDE IN-VIVO LOADING OF THE DEVICE POSSIBLY CAUSING A FATIGUE FRACTURE AND POSSIBLY IN CONJUNCTION WITH BENDING/STRESSING THE PLATE PRIOR TO IMPLANTATION AS WELL AS PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL. PER PRODUCT DIRECTIONS FOR USE (DFU-0192), POST-OPERATIVELY, UNTIL BONE HEALING IS COMPLETE, FIXATION GIVEN WITH THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS AND UNTIL HEALING IS COMPLETE THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POST-OPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AR-8009-20 DOUBLE COMPRESSION PLATE WAS USED FOR A CALCANEOCUBOID FUSION SURGERY A YEAR AGO. THE SURGEON NOTICED AT THE YEAR POST-OP APPOINTMENT THAT THE JOINT DID NOT FUSE AND THE PATIENT WILL REQUIRE A SECOND SURGERY. WHEN THE SECOND SURGERY WAS BEING PERFORMED ON (B)(6) 2016, THE SURGEON NOTICED THAT THE ARMS OF THE DOUBLE COMPRESSION PLATE WAS BROKEN. THE SURGEON ALSO REPORTED THAT THE NON-UNION OF THE JOINT MAY ALSO HAVE BEEN DUE TO THE PATIENT'S SOFT BONE CONDITION. THE PLATE AND 4 SCREWS (PART/LOT NUMBERS UNKNOWN) WERE REMOVED FROM THE PATIENT. THE SCREWS WERE DISCARDED IN BIO-HAZARD. ANOTHER MANUFACTURER'S PRODUCT WAS IMPLANTED IN ITS PLACE, AND AN METATARSOPHALANGEAL FUSION WAS ALSO PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AR-8009-20 DOUBLE COMPRESSION PLATE WAS USED FOR A CALCANEOCUBOID FUSION SURGERY A YEAR AGO. THE SURGEON NOTICED AT THE YEAR POST-OP APPOINTMENT THAT THE JOINT DID NOT FUSE AND THE PATIENT WILL REQUIRE A SECOND SURGERY. WHEN THE SECOND SURGERY WAS BEING PERFORMED ON (B)(6) 2016, THE SURGEON NOTICED THAT THE ARMS OF THE DOUBLE COMPRESSION PLATE WAS BROKEN. THE SURGEON ALSO REPORTED THAT THE NON-UNION OF THE JOINT MAY ALSO HAVE BEEN DUE TO THE PATIENT'S SOFT BONE CONDITION. THE PLATE AND 4 SCREWS (PART/LOT NUMBERS UNKNOWN) WERE REMOVED FROM THE PATIENT. THE SCREWS WERE DISCARDED IN BIO-HAZARD. ANOTHER MANUFACTURER'S PRODUCT WAS IMPLANTED IN ITS PLACE, AND AN METATARSOPHALANGEAL FUSION WAS ALSO PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305838 4 HOLE DOUBLE COMPRESSION PLATE PLATE, FIXATION, BONE HRS ARTHREX, INC. 140247

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other