BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN PLATE 4-HOLES STR W/ STEM HAND-M

    MDR report key: 4894142 · Received July 2, 2015

    Report

    Report Number
    9613350-2015-00714
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    February 13, 2015
    Report Date
    June 2, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED BY (B)(4) AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. A SURGICAL REPORT DATED (B)(6) 2015 WAS PROVIDED. THE SUMMARY OF THAT REPORT IS: DIAGNOSIS. FRACTURE OF OTHER METACARPALS BONES. THE WOUND IS OPEN AND NO PUS WAS SEEN ON THE HEALING TISSUE ON THE AREA OF THE PLATE. THE MATERIAL IS LOOSE AND THE PLATE IS EXTRACTED WITH NO SECRETION. OSTEOLYSIS ON THE FRAGMENTS OF THE PROXIMAL AND DISTAL WITH LOOSE OF BONE. THE PLATE AND TWO SCREWS WERE RETURNED FOR INVESTIGATION. THE VISUAL EXAMINATION SHOWS THE PLATE AND THE TWO SCREWS DO NOT SHOW ANY DEFORMATION OR ABNORMALITY. THE SCREWS DO ONLY SHOW SIGNS OF USAGE. ON THE PLATE THERE IS NO EVIDENCE THAT SHOULD CAUSED THE OSTEOLYSIS. SOME SCRATCHES AND POLISHED AREAS CAN BE SEEN. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA FOR A SIMILAR DEVICE: LINE 7: LOOSENING OF THE PLATE DUE TO CUT OUT, PULL OUT OF THE IMPLANT; LINE 24: LOOSENING OF THE PLATE DUE TO WRONG COMBINATION OF PLATES AND SCREWS; LINE 28: LOOSENING OF THE PLATE DUE TO IMPLANTATION OF A DAMAGED IMPLANT; LINE 29: LOOSENING OF THE PLATE DUE TO OFF LABEL USE OF IMPLANTS. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: POSSIBLE: AS THERE ARE NO X-RAYS PROVIDED, THIS POINT CANNOT BE EXCLUDED; NOT POSSIBLE: ACCORDING TO THE INVESTIGATION RESULTS, THE COMBINATION OF THE PLATE AND SCREWS IS CORRECT; POSSIBLE: IT CAN BE THAT A DAMAGED IMPLANT WAS IMPLANTED; POSSIBLE: AS NO FURTHER INFORMATION ABOUT THE SURGICAL STEPS IS AVAILABLE. NO X-RAYS PROVIDED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, IT WAS NOT POSSIBLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADD'L INFO RECEIVED ON JULY 9, 2015. THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NOT LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION BUT IT IS MENTIONED BY COMPLAINANT THAT IT WILL BE PROVIDED. NO X-RAYS WERE PROVIDED FOR REVIEW. AS INCORRECT LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/ OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A TITAN PLATE 4-HOLES STR W/ STEM HAND-M ON AN UNKNOWN DATE AND THAT THE MATERIAL WAS REMOVED ON (B)(6) 2015 BECAUSE THE PATIENT PRESENTED OSTEOLYSIS. IT WAS REPORTED THAT THE PLATE AND THE SCREWS WERE REMOVED WITHOUT PRESENCE OF PUS.

    Description of Event or Problem · 1

    IT HAS NOT BEEN REPORTED THAT THE PT WAS IMPLANTED A TITAN PLATE 4-HOLES STR WITH STRM HAND-M ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431322 TITAN PLATE 4-HOLES STR W/ STEM HAND-M NORMED EXTREMITY TITANIUM HAND AND SMA HRS NORMED MEDIZIN-TECHNIK GMBH NA 11191/301B12

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R