BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 6548702 · Received May 5, 2017

    Report

    Report Number
    3003875359-2017-10220
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    April 16, 2017
    Report Date
    April 16, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART # 03.010.045, SYNTHES LOT # 4984114: RELEASE TO WAREHOUSE DATE: 20-JUL-2005, EXPIRATION DATE: NA, MANUFACTURED BY: BRANDYWINE: NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE RETURNED SUBJECT DEVICE. ONE STANDARD INSERTION HANDLE (PART# 03.010.045 LOT# 4984114) AND ONE 12.0MM/8.0MM PROTECTION SLEEVE188MM (PART# 03.010.036 LOT# 1639501) WERE RECEIVED AT CUSTOMER QUALITY (CQ) FOR EVALUATION WITH COMPLAINT CATEGORY DEVICE INTERACTION: DOES NOT FIT WITH OTHER PARTS. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED AND REPLICATED, AS THE PROTECTION SLEEVE IS UNABLE TO BE REMOVED FROM THE STANDARD INSERTION HANDLE. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, EXCESSIVE USE AND MECHANICAL OVERLOADING OR REPETITIVE REPROCESSING OF THE DEVICES MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ALTHOUGH THE PROCEDURE WAS UNSPECIFIED, BOTH INSTRUMENTS ARE BOTH A PART OF THE SUPRAPATELLAR INSTRUMENTATION FOR TITANIUM CANNULATED TITANIUM NAIL SYSTEM AND ARE USED FOR NAIL ALIGNMENT DURING INSERTION AND EXTRACTION PROCEDURES. THE INNER DIAMETER MEASUREMENTS OF THE STANDARD INSERTION HANDLE WERE NOT ABLE TO BE TAKEN, AS THE PROTECTION SLEEVE CANNOT BE REMOVED. THE OVERALL CONDITION OF THE RETURNED DEVICE IS GOOD, WITH MINOR SCRATCHES AND SIGNS OF WEAR ON THE DEVICE. RELEVANT DRAWING FOR THE DEVICE WAS REVIEWED, AND NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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

    ADDITIONAL NARRATIVE: PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 WAS REPORTED THAT WHILE TESTING THE SCREW TARGETING ON THE BACK TABLE, THE PROTECTION SLEEVE WOULD NOT PASS THROUGH THE INSERTION HANDLE. THERE WAS NO PATIENT HARM, NO REPORTED SURGICAL DELAY OR ADDITIONAL INTERVENTION. THERE ARE TWO DEVICES INVOLVED IN THIS COMPLAINT. THIS REPORT IS FOR ONE (1) STANDARD INSERTION HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330557 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 4984114

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR