BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.5MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE

    MDR report key: 3679188 · Received March 14, 2014

    Report

    Report Number
    1719045-2014-10054
    Event Type
    Injury
    Date Received
    March 14, 2014
    Report Date
    February 21, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK120807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT THE: ONE OF THE FOLLOWING WAS RECEIVED WITH NO REPORTED PRODUCT PROBLEM: TI MULTILOC HUMERAL NAIL (04.018.240 / LOT # 5920322 / MFG LOCATION: (B)(4)/ MFG. DATE: 12/2012), TI MULTILOC END, FOR MULTILOC NAIL, 5MM EXTENSION (04.019.005 / LOT # 5910270 / MFG LOCATION: (B)(4)/ MFG. DATE: 04/2011), 4.5MM TI MULTILOC SCREW, 36MM (04.019.036 / LOT # UNKNOWN / MFG LOCATION: UNKNOWN / MFG. DATE: UNKNOWN), 4.5MM TI MULTILOC SCREW, 34MM (04.019.034 / LOT # UNKNOWN / MFG LOCATION: UNKNOWN / MFG. DATE: UNKNOWN), 4.5MM TI MULTILOC SCREW, 26MM (04.019.026 / LOT # UNKNOWN / MFG LOCATION: UNKNOWN / MFG. DATE: UNKNOWN), 4.0MM LOCKING SCREW, 26MM (04.005.416 / LOT # UNKNOWN / MFG LOCATION: UNKNOWN / MFG. DATE: UNKNOWN), 4.0MM LOCKING SCREW, 24MM (04.005.414 / LOT # UNKNOWN / MFG LOCATION: UNKNOWN / MFG. DATE: UNKNOWN). THE FOLLOWING DRAWINGS WERE REVIEWED FOR THE IMPLANTS AND ARE DETERMINED TO BE SUITABLE FOR THE DESIGN AND RELATED DIMENSIONAL CONFORMITY: SE_425518, REV. E, 04_019_002, REV. B, 04_019_020, REV A, AND 04_005_408, REV. F. THE RETURNED IMPLANTS ARE IN GOOD, FUNCTIONAL CONDITION. THE BLUE ANNODIZATION IS WORN IN MULTIPLE PLACES ON THE PROXIMAL PORTION OF THE NAIL, INCLUDING A SMALL PORTION OF THE LASER MARKING; ONE GOUGE IS PRESENT ON THE DISTAL TIP. END CAP IS INTACT AND FUNCTIONAL, WITH ONLY A FEW GOUGES AROUND THE HEX DRIVE. THE MULTILOC SCREWS ARE IN EXCELLENT CONDITION; THREADS ARE INTACT AND FUNCTIONAL. THE THREADS ON THE DISTAL LOCKING SCREWS ARE WORN AND ROLLED IN THE MIDDLE-DISTAL PORTION. THE RETURNED IMPLANTS ARE INDICATED FOR FRACTURES OF THE PROXIMAL HUMERUS; 2, 3, AND 4-PART SURGICAL NECK FRACTURES; FRACTURES OF THE PROXIMAL HUMERUS WITH DIAPHYSEAL EXTENSION; DIAPHYSEAL FRACTURES OF THE HUMERAL SHAFT; AND IMPENDING PATHOLOGICAL FRACTURES. PROPER USE IS ADDRESSED IN TECHNIQUE GUIDE J9981-B. THE RETURNED IMPLANTS WERE USED IN A SEGMENTAL FRACTURE OF THE HUMERUS, BUT DUE TO A LACK OF INFORMATION INCLUDING X-RAYS BEING UNOBTAINABLE, WE CANNOT ASCERTAIN THE EXACT CAUSE FOR THE DELAYED HEALING. BUT SINCE THE IMPLANTS WERE REMOVED INTACT AND FUNCTIONAL, IT IS DETERMINED THAT THE DESIGN OF THE IMPLANTS DID NOT CONTRIBUTE TO THIS COMPLAINT, AND THIS COMPLAINT. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED DUE TO NOT ENOUGH INFORMATION, METHOD OF USE COULD HAVE BEEN A CAUSE. IT IS DETERMINED THAT THE IMPLANT'S DESIGN WAS NOT A FACTOR. BECAUSE OF THIS, THE COMPLAINT IS DETERMINED NOT TO BE A DESIGN DEFICIENCY. THE RETURNED PART(S) ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. 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

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO COMPLAINT ISSUES WERE FOUND. 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

    IT WAS REPORTED THAT A PATIENT FAILED TO RECOVER AFTER A RIGHT HUMERAL INTRAMEDULLARY NAILING ON (B)(6) 2013 FOR A SEGMENTAL FRACTURE. THE IMPLANTED NAIL AND SCREWS WERE REMOVED ON (B)(6) 2014, AND THE FRACTURE IS HEALING. THIS COMPLAINT IS REGARDING 1 HUMERAL NAIL, 5 SCREWS, AND ONE END CAP.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154610 8.5MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 5920322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention