BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE

    MDR report key: 5496090 · Received March 11, 2016

    Report

    Report Number
    3003862213-2016-10004
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Date of Event
    February 23, 2016
    Report Date
    February 23, 2016
    Manufacturer
    UMKIRCH
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED INSTRUMENTS WERE EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE CERCLAGE PASSER (03.221.011 LOT 9142560) TIPS DID NOT ALIGN WHEN CLOSED. THE RETURNED DEVICE WAS ASSEMBLED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS LEFT AND RIGHT TIPS DO NOT ALIGN ONCE THE INSTRUMENT IS ASSEMBLED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF EXCESSIVE FORCE DURING INSERTION. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL, RIGHT TUBE, AND LEFT TUBE. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOTS NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT DOB & WEIGHT NOT PROVIDED BY REPORTER. ADDITIONAL PRODUCT CODE: FSM. (B)(4). LOT NUMBER UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 15.DEC.2014, 03.221.011, LOT 9142560. 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. 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

    REMOVE ADVERSE EVENT FROM COMPLAINT. (B)(4). LOT NUMBER UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED. 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

    IT IS REPORTED PATIENT WAS IMPLANTED WITH COMPETITOR'S TOTAL HIP IMPLANT ON UNKNOWN DATE. PATIENT SUFFERED A RIGHT PERIPROSTHETIC FEMUR FRACTURE STARTING AT THE GREATER TORCH AND EXTENDING DISTALLY IN A SPIRAL FASHION PAST THE BASE OF THE STEM. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 FOR IMPLANT OF A PROXIMAL FEMORAL HOOK PLATE AND CABLES TO BRIDGE THE STEM AND FIX THE FRACTURE. DURING THE PROCEDURE, THE CERCLAGE PASSER WOULD NOT ALIGN TO ALLOW THE CABLE TO PASS THROUGH. IT WAS ALSO REPORTED THAT THE HANDLE OF A SCREWDRIVER BROKE WHILE TIGHTENING A SCREW. NO FRAGMENTS WERE GENERATED. BACKUP DEVICES WERE READILY AVAILABLE AND WERE USED TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO HARM TO PATIENT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151777 CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE MISC ORTHO SURGICAL INSTR LXH UMKIRCH 9142560

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention