BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP HOLDING FORCEPS

    MDR report key: 6278128 · Received January 25, 2017

    Report

    Report Number
    2520274-2017-10278
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    July 27, 2016
    Report Date
    January 6, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THERAPY DATE: UNKNOWN DATE IN 2012. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE RETURNED INSTRUMENT WAS EXAMINED AT CUSTOMER QUALITY AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED. THE TWO MEDIAL FACING PRONGS OF THE DEVICE HAD SHEARED OFF. THESE FRAGMENTS WERE NOT RETURNED WITH THE COMPLAINT AND THE PIECE REPORTED TO THE LODGED IN THE HOOK CAP WAS NOT LOCATED. REPLICATION OF THE COMPLAINT IS NOT APPLICABLE. WHILE THE ROOT CAUSE IS LIKELY A RESULT OF THE METHOD OF USE, SINCE THE SPECIFIC CONDITIONS AT THE TIME OF THE ISSUE ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. A VISUAL INSPECTION, DEVICE HISTORY RECORD REVIEW (DHR), AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. ONE (1) RIB HOOK CAP (PART 04.641.005, LOT 7282227) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. THE RETURNED INSTRUMENT IS PART OF THE DEPUY SYNTHES VEPTR II SYSTEM. THE CAP HOLDING FORCEPS ARE UTILIZED TO INSERT THE RIB HOOK INTO THE INTERCOSTAL SPACE SUPERIOR TO THE RIB AND TO MATE WITH THE RIB SUPPORT. ADDITIONALLY, THE CAP HOLDING FORCEPS ARE USED TO PLACE RIB HOOK EXTENSIONS IF MULTIPLE RIB ATTACHMENTS IS DESIRED (PER TECHNIQUE GUIDE). PRODUCT DRAWING WAS REVIEWED. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. WHILE THE ROOT CAUSE IS LIKELY A RESULT OF THE METHOD OF USE, SINCE THE SPECIFIC CONDITIONS AT THE TIME OF THE ISSUE ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE REPORTABILITY HAS BEEN CORRECTED FROM SERIOUS INJURY, REPORTABLE MALFUNCTION (REPORTED IN (B)(4)) TO REPORTABLE MALFUNCTION ONLY AS THE REPORT STATES THE PRONGS BROKE OFF OF THE RIB HOOK HOLDER AND NO BROKEN FRAGMENTS WERE LEFT IN THE PATIENT. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON PART # 03.641.006, LOT # A7QA39. MANUFACTURING DATE: 28-SEP-2007. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR IMPORTANT FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 28-SEP-2007. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    SYNTHES CUSTOMER QUALITY RECEIVED A MEDWATCH USER FACILITY REPORT ON JANUARY 6, 2017 REPORTING THAT ¿DURING A TITANIUM RIB PROCEDURE [ON (B)(6) 2016], A CRADLE CAP HOLDER [RIB HOOK HOLDER] WAS USED TO REMOVE A CRADLE CAP [SUPERIOR RIB HOOK CAP]. THE INSTRUMENT HAS TWO (2) SMALL PRONGS WHICH BROKE OFF. ONE IS STUCK IN THE CRADLE. THE SECOND HAS BEEN REMOVED FROM THE PATIENT." THE PROCEDURE WAS A PRE-PLANNED, SCHEDULED PROSTHETIC TITANIUM RIB EXPANSION PROCEDURE, INVOLVING THE REPLACEMENT OF RIGHT VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) PROSTHESIS, RESEATING THE SUPERIOR RIB HOOK CAP OF THE RIGHT VEPTR PROSTHESIS, AND EXPANSION OF BILATERAL VEPTR PROSTHESIS. THE PRONGS ON THE RIB HOOK HOLDER BROKE OFF WHEN REMOVING THE RIB HOOK CAP. ONE PRONG REMAINED IN THE RIB HOOK, AND ONE WAS RETRIEVED FROM THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: RIB HOOK CAP (PART # 04.641.005, LOT # 7282227, QTY.1) UNKNOWN RIB HOOK (PART # UNKNOWN, LOT NUMBER UNKNOWN, QTY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO INSTRUMENT FRAGMENTS WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59811 CAP HOLDING FORCEPS FORCEPS HTD SYNTHES TUTTLINGEN A7QA39

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention 04.641.005, TI RIB HOOK CAP/EXTENDED, QTY 1| UNKNOWN RIB HOOK, QTY 1