BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE 188MM

    MDR report key: 6048515 · Received October 21, 2016

    Report

    Report Number
    3003875359-2016-10550
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 4, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS CONDUCTED /PERFORMED. THE REPORT INDICATES THAT: THE MEASURED OUTSIDE DIAMETER DID PASS THE SPECIFICATIONS. THE COMPLAINED PROBLEM SUCH AS (TIGHTNESS BECAUSE THE SLEEVE DID NOT GO THROUGH THE AIMING ARM SMOOTHLY) COULD NOT BE CONFIRMED BASED ON THE TAKEN MEASUREMENTS AND THE FUNCTIONAL CHECK TOGETHER WITH SUSTAINING ENGINEERING. 1X ARTICLE 03.019.008 LOT: 9879830 / 1X ART: 03.019.013 LOT: 8364361 // 1X ART: 03.019.013 LOT: 8404282 // 1X ART: 03.010.063 LOT: 8326169 / 1X ART: 03.010.063 LOT: 8780671 RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS PERFORMED TOGETHER WITH STAFF FROM SUSTAINING ENGINEERING AND THE RESULT WAS THAT THE SLEEVES DO CLAMP IN THE HOLES OF AIM-ARM LIKE INTENDED. THE SLEEVES DO NEED TO BE TIGHT IN ORDER THAT THE AIM-ARM CAN BE TURNED DOWNWARDS AND NOT LOSING THE SLEEVES. THE OUTSIDE DIAMETERS OF THE SLEEVES WERE MEASURED AND NO DEVIATION FOUND. ON THE AIM-ARM THERE ARE SOME MARKS OF USE VISIBLE AND IS INDICATED WITH GREEN ARROW. THE SLEEVES ARE IN USED BUT FUNCTIONAL CONDITION AS IT IS THE AIM-ARM AS WELL. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATION TO THE SPECIFICATIONS. NO MANUFACTURING RELATED FAULT OR FAILURE COULD BE DETECTED / FOUND. COMPLAINT UNCONFIRMED. DEVICE 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED. 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. THE MANUFACTURING EVALUATION SHOWS, THE SLEEVE IS IN A SLIGHT USED CONDITION. THE MEASURED OUTSIDE DIAMETER DID PASS THE SPECIFICATIONS. NO MANUFACTURING RELATED FAILURE DETECTED. 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 AN AIMING ARM AND FOUR (4) PROTECTION SLEEVES WERE USED DURING SURGERY ON THE PROXIMAL HUMERUS FRACTURE ON (B)(6) 2016. THE SURGEON CONNECTED A NAIL TO AN INSERTION HANDLE FOR THE DRY CHECKUP. WHEN THE NURSE DOUBLE-CHECKED THE DEVICE, SHE FELT TIGHTNESS BECAUSE THE SLEEVE DID NOT GO THROUGH THE AIMING ARM SMOOTHLY. SO SHE SOAKED THE AIMING ARM AND THE TWO (2) SLEEVES IN PHYSIOLOGICAL SALINE SOLUTION. AS SHE MADE THE SECOND TRY, THE TIGHTNESS BECAME ALLEVIATED SOMEHOW. THE SURGERY WAS EXTENDED FOR FIVE (5) MINUTES. CONCOMITANT DEVICES: NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698896 12.0MM/8.0MM PROTECTION SLEEVE 188MM MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8326169

    Patients

    Seq Age Sex Outcome Treatment
    1 INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUA| NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1)