BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM THREADED GUIDE WIRE 150MM

    MDR report key: 3870737 · Received June 12, 2014

    Report

    Report Number
    2520274-2014-11817
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE FOLLOWING PARTS ARE ALSO INCLUDED IN THE SET. SYNTHES CANNOT IDENTIFY WHETHER OR NOT THEY WERE USED DURING THE PROCEDURE WITH THE PATIENT: 304.49 EXEMPT FSM, 309.501 EXEMPT HXX, 310.221 K962913 HWE, HSZ, GFA, GFF, 310.804 EXEMPT HWW, 311.43 EXEMPT HWX, 312.151 EXEMPT FZX, 312.153 EXEMPT FZX, 313.969 EXEMPT HXX, 314.463 EXEMPT HXX, 314.464 EXEMPT HXX, 314.465 EXEMPT HXX, 319.291 EXEMPT LXH, 319.292 EXEMPT LXH, 319.702 EXEMPT HTJ, 319.97 EXEMPT HTD, 398.408 EXEMPT HTE, 398.409 EXEMPT HTE, 402.608-402.640 K962823 HWC, 402.714-402.740 K962823 HWC, 419.89 K962823 HTN, 419.972 PRE-AMENDMENT HTN, 292.623 EXEMPT FZX DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE WAS RECEIVED FOR EVALUATION (DATE UNSPECIFIED). INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. RESIDUAL TESTING WAS PERFORMED ON THE SET. THE RESULTS SHOWED ON (B)(6) 2014 THAT THE IMPLANTS ARE CYTOTOXIC AND FURTHERMORE SOME NON-VOLATILE MATERIALS (YET TO BE IDENTIFIED) ALSO ARE BEING IDENTIFIED. 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

    (B)(4). 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 THE 3.0 MM TI CANNULATED SCREW INSTRUMENT AND IMPLANT SET (P/N 145.17) WAS SUBMERGED IN WATER AFTER A STORM, HURRICANE SANDY. THE SALES CONSULTANT¿S CAR AND THE SET WERE COMPLETELY UNDER WATER FOR A FEW HOURS, POSSIBLY LONGER; SUBSEQUENTLY, THE SET WAS SOAKED. SALES CONSULTANT ALSO MENTIONED THAT WHEN HE LOOKED INSIDE THE SET THERE WAS SAND/SEDIMENT/MUD AND REMEMBERS SOME OXIDATION/RUST ON PARTS OF THE SET (HE COULDN¿T BE SPECIFIC). THE SET WAS SUPPOSED TO BE SET ASIDE TO BE DISPOSED OF BUT WAS INADVERTENTLY MISSED. WHEN RETURNED TO THE SYNTHES FACILITY, THE SET WAS DECONTAMINATED AND SENT OUT TO BE USED BY A HOSPITAL. REPORTEDLY THE FIRST TIME IT WAS SHIPPED OUT, THE SET WAS NOT USED AND WAS SENT BACK UNUSED. THE SET WAS THEN DECONTAMINATED AGAIN WHEN IT WAS RETURNED AND EVENTUALLY SENT OUT TO A HOSPITAL WHERE IT WAS USED. THE SET WAS RETURNED AND USED 4 TIMES TOTAL AFTER BEING INVOLVED IN THE HURRICANE. PER AN ORDER REPORT FROM (B)(6) 2013, FOUR DEVICES (PARTS 292.622 AND 402.615 TWO OF EACH) WERE BILLED FOR USAGE AND USED ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED TO DATE. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347984 1.1MM THREADED GUIDE WIRE 150MM GUIDE FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1