BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 5830023 · Received July 28, 2016

    Report

    Report Number
    1719045-2016-10573
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Report Date
    July 12, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 31-MAY-2016, EXPIRATION DATE: 31-DEC-2025, PART #: 04.037.142S, LOT#: 9960203 (STERILE) - 11MM/130 DEG TI CANN TFNA 170MM - STERILE. RAW MATERIAL LOT NO: 9814902. 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. SCN NO: (B)(4), "STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING." THE EVENT AS PER COMPLAINT DESCRIPTION CANNOT BE ASSOCIATED WITH THE STERILITY PROCESS OF THE PRODUCT SUBJECT DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE RETURNED IMPLANT IS PART OF THE DEPUY SYNTHES TFNA ADVANCED (TFNA) PROXIMAL FEMORAL NAILING SYSTEM. THE HELICAL BLADE IS USED TO PREVENT THE NAIL FROM ROTATING ONCE FINAL POSITION AND LOCKING HAS TAKEN PLACE. BASED ON THE X-RAYS PROVIDED ABOVE (X-RAYS_POST-OPERATIVELY.PDF) THE BLADE IS SEEN PROTRUDING TOWARDS THE FEMORAL HEAD. VISUAL INSPECTION OF THE IMPLANT SHOWED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT AS BLADE IS IN FAIR CONDITION WITH WEAR CONSISTED WITH BEING IMPLANTED/EXPLANTED. THE IMPLANT WAS TESTED WITH THE CONCOMITANT DEVICE (11MM/130 DEG TI CANN TFNA 170MM - STERILE; PART NUMBER: 04.037.142S LOT NUMBER 9960203) AND SHOWED NO ISSUES. THE FOLLOWING COMPLAINT DEVICE WAS RECEIVED BY CUSTOMER QUALITY (CQ): ONE TFNA HELICAL BLADE 90MM STERILE (PART NUMBER: 04.038.290S, LOT NUMBER: 9806819, MFG. DATE: 29JUN2015) THE DEVICE WAS RECEIVED WITH THE FOLLOWING COMPLAINT DESCRIPTION: "SURGICAL REVISION TOOK PLACE ON (B)(6) 2016 TO REPLACE WITH ARTIFICIAL FEMORAL HEAD DUE TO PROTRUDING THE REPORTED BLADE (OF TFNA) FROM THE HEAD OF THE FEMUR." THE COMPLAINT CONDITION IS CONFIRMED. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT, WHERE APPLICABLE, WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. PLEASE NOTE 04.037.142S LOT NUMBER 9960203 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. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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 (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2016, TO REPLACE A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) BLADE WHICH WAS PROTRUDING FROM THE PATIENT'S FEMORAL HEAD. THE PATIENT WAS REVISED WITH A PROSTHETIC FEMORAL HEAD. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016. THE FOLLOWING COMMENTS WERE FURTHER REPORTED: "THE SURGEON REDUCED THE REPORTED BLADE EXTRAMEDULLARY DURING THE SURGERY; THE REPORTED BLADE GRADUALLY MIGRATED INTRAMEDULLARY 1 TO 2 WEEKS AFTER THE SURGERY; THE MIGRATION MIGHT OCCUR DUE TO THE NAIL BEING PLACED POSTERIORLY A LITTLE BIT DURING THE SURGERY; ALTHOUGH THE PATIENT FELL FROM BED [ON AN UNKNOWN DATE] IN (B)(6) 2016 ONCE, IT MIGHT NOT BE THE EXACT CAUSE OF THIS TROUBLE ITSELF." NO SURGICAL DELAY WAS REPORTED DURING THE REVISION SURGERY. THIS COMPLAINT INVOLVES 3 PARTS. CONCOMITANT PART: 1X 04.005.522 / 9637938 (LOCKSCR Ø5 L32 F/NAILS TAN LIGHT GREEN). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483278 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9960203

    Patients

    Seq Age Sex Outcome Treatment
    1 1X 04.005.522 / 9637938 (LOCKSCR Ø5 L32 F/NAILS TA