BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI END CAP T25 STRDRV 0MM EXT HUMERAL NAIL-EX SPIRAL BLADE

    MDR report key: 6492101 · Received April 13, 2017

    Report

    Report Number
    1719045-2017-10308
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    March 27, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    UDI-DI
    07611819780651
    PMA / PMN Number
    K033071
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED CONDITION: ALL PARTS WERE RECEIVED IN USED CONDITION BUT IN FULL FUNCTION. PARTS WERE FORWARDED TO SUSTAINING ENGINEERING FOR PD EVALUATION AND FUNCTIONAL TEST. 462.636 / 8274114 SPIRAL BLADE: DHR REVIEW OF COMPLAINED SPIRAL BLADE SHOWS THAT THIS SPECIFIC LOT WAS RELEASED AFTER COMPLETE FINAL INSPECTION WITH NO FINDINGS IN JANUARY 2013. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 04.001.000 / H102298 END CAP: DHR REVIEW OF COMPLAINED END CAP SHOWS THAT THIS SPECIFIC LOT WAS RELEASED AFTER COMPLETE FINAL INSPECTION WITH NO FINDINGS IN AUGUST 2016. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CONCOMITANT DEVICES ARE IN USED BUT FAULTLESS CONDITION AS WELL. NO PRODUCT FAULT COULD BE DETECTED. WE ARE NOT ABLE TO IDENTIFY THE ROOT CAUSE FOR THE REPORTED PROBLEM. THE COMPLAINT IS RATED AS CONFIRMED DUE TO RECEIVED X-RAY PICTURES BUT INVALID FROM PRODUCT INVESTIGATION RESULTS. THE HANDLING TEST DEMONSTRATED THAT THE BLADE CAN BE SUCCESSFULLY SECURED BY MEANS OF THE END CAP. MOREOVER, THE BLADE LOCKING COULD WITHSTAND MANUAL PULL-OUT AND PUSH-OUT FORCES. AFTER THE PERFORMANCE OF THE HANDLING TEST, TWO PRESSURE MARKS WERE OBSERVED WITH UNAIDED EYES ON THE LATERAL SECTION OF THE SPIRAL BLADE. THE HARM AND RATE OF OCCURRENCE OF THE SOURCE COMPLAINT ARE ADEQUATE ADDRESSED IN THE CURRENT RISK MANAGEMENT DOCUMENT. NO PRODUCT FAULT COULD BE DETECTED. WE ARE NOT ABLE TO IDENTIFY THE ROOT CAUSE FOR THE REPORTED PROBLEM. THE COMPLAINT IS RATED AS CONFIRMED DUE TO RECEIVED X-RAY PICTURES BUT INVALID FROM PRODUCT INVESTIGATION RESULTS. 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

    ADDITIONAL BRAND NAME: EXPERT END CAP SOLID EXTENS. 0 F/HN TAN. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PART #: 04.001.000, LOT#: H102298 (NON-STERILE) - TI END CAP T25 STARDRV 5MM EXT HUMERAL NAIL-EX SPIRAL BLADE. QUANTITY (B)(4). COMPONENTS: PART NO 21022 LOT 5584284 WAS REVIEWED. INSPECTION SHEET FOR INCOMING INSPECTION MET INSPECTION CRITERIA. CERTIFICATE OF COMPLIANCE RECEIVED FROM SUPPLIER MET SPECIFICATION. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 01-AUG-2016. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR A PROXIMAL HUMERAL FRACTURE. PATIENT FELL ON UNKNOWN DATE; X-RAYS TAKEN ON (B)(6) 2017 REVEALED THE SPIRAL BLADE HAD CUT OUT. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REMOVAL OF THE SPIRAL BLADE. DURING THIS PROCEDURE IT WAS NOTED THE END CAP HAD LOOSENED, CAUSING THE SPIRAL BLADE TO CUT OUT. THIS REPORT IS FOR ONE (1) END CAP. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274151 TI END CAP T25 STRDRV 0MM EXT HUMERAL NAIL-EX SPIRAL BLADE NAIL,FIXATION,BONE JDS SYNTHES MONUMENT H102298 07611819780651

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention