BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 6174694 · Received December 15, 2016

    Report

    Report Number
    2520274-2016-15680
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDS
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.440, LOT# 160139-101. MANUFACTURING LOCATION: (B)(6), MANUFACTURING DATE: (B)(6) 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED FOR PART# 03.010.440, LOT# 160139-101. A VISUAL INSPECTION, FUNCTIONAL TEST, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE DEVICES WERE EACH RECEIVED INTACT. ONE OF THE TWO LOCATING DOWEL PINS ON THE AIMING ARM IS BENT OUTWARD PREVENTING PROPER ALIGNMENT/SEATING OF THE INSERTION HANDLE. THE RETURNED INSERTION HANDLE SHOWS NO DAMAGE OR WEAR. THIS COMPLAINT IS CONFIRMED. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED AT CUSTOMER QUALITY. A REVIEW OF THE DESIGN DRAWINGS (CURRENT/MANUFACTURED REVISION) WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE BENT PIN. THE DAMAGE (BENT PIN) IS MOST LIKELY THE RESULT OF ROUGH HANDLING DURING PREVIOUS USE OR DURING STERILE PROCESSING. 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

    THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. (B)(4). 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 DURING AN IN-SERVICE TRAINING FOR RESIDENTS AT THE HOSPITAL, USING THE SUPRAPATELLAR SET, IT WAS NOTED THAT THE INSERTION HANDLE WOULD NOT ATTACH TO THE AIMING ARM FOR DEMONSTRATION PURPOSES. THERE WERE REPORTEDLY NO PROBLEMS WITH ANY OF THE OTHER INSTRUMENTS IN THE SET. THE IN-SERVICE TRAINING DID NOT INVOLVE ANY PATIENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829222 INSERTION HANDLE FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS SYNTHES SELZACH 160139-101

    Patients

    Seq Age Sex Outcome Treatment
    1