BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR LARGE SCREWS

    MDR report key: 4748002 · Received May 5, 2015

    Report

    Report Number
    2520274-2015-13592
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Report Date
    April 16, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: DEPTH GAUGE-1 (PART 319.01 / LOT 8080549 / MANUFACTURE DATE: 10/2012); DEPTH GAUGE-2 (PART 319.006 / LOT 6138150 / MANUFACTURE DATE: 05/2009); DEPTH GAUGE-3 (PART 319.006 / LOT 6770210 / MANUFACTURE DATE: 09/2011); DEPTH GAUGE-4 (PART 319.006 / LOT 7151460 / MANUFACTURE DATE: 09/2013)THE RETURNED DEPTH GAUGES SHOW SIGNS OF REGULAR USAGE, WITH VARIOUS SCRATCHES AND MARKS. GAUGE-1 HAS NO FUNCTIONAL DAMAGE BUT IS MISSING THE HEADPIECE/PIN ASSEMBLY. COMPONENT WAS MOST LIKELY LOST DURING STERILE PROCESSING. REMAINING DEVICES (GAUGE-2, GAUGE-3, AND GAUGE-4) HAVE THE MEASURING NEEDLE BROKEN OFF AT THEIR INTERFACE TO THE BLACK GRADUATED ROD. THIS DAMAGE MOST LIKELY OCCURRED DURING STERILE PROCESSING. A VISUAL INSPECTION, DIMENSIONAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE DRAWING FOR THE DEVICE(S) WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGNS ARE ADEQUATE FOR THEIR INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED INSTRUMENT(S) ARE ADDITIONAL INSTRUMENTS USED DURING IMPLANTATIONS TO MEASURE SCREW SIZES AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN NUMEROUS TECHNIQUE GUIDES. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THIS COMPLAINT CONDITION IS POSSIBLY A RESULT OF METHOD OF USE AND INATTENTIVENESS DURING STERILIZATION. AN INSPECTION OF THE RETURNED COMPONENTS SHOWED NO DESIGN ISSUES. THE RETURNED PART(S) ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED, BUT THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. 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

    SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE HEAD PIECE AND COLLAR WERE MISSING. THE REPAIR TECHNICIAN REPORTED MISSING PARTS AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: KNURLED CAP, HEAD PIECE. THIS ITEM WAS REPAIRED, PASSED SYNTHES FINAL INSPECTION, AND RETURNED TO THE CUSTOMER ON MAY 14, 2015.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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL DEVICES WERE DISCOVERED TO BE BROKEN OR DAMAGED DURING STERILE PROCESSING. THE NEEDLE FOR THREE (3) DEPTH GAUGES FOR 2.0MM AND 2.4MM SCREWS HAD BROKEN OFF. ADDITIONALLY, IT WAS DISCOVERED THAT THE HEAD PIECES AND COLLARS WERE MISSING FROM TWO OTHER DEVICES (DEPTH GAUGES FOR 2.7MM AND SMALL SCREWS AND DEPTH GAUGES FOR LARGE SCREWS). THE EVENTS DID NOT OCCUR DURING A PROCEDURE AND, THEREFORE, RESULTED IN NO PATIENT HARM OR SURGICAL DELAY. THIS REPORT IS 5 OF 5 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292420 DEPTH GAUGE FOR LARGE SCREWS GAUGE, DEPTH HTJ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1