BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 5900336 · Received August 24, 2016

    Report

    Report Number
    1719045-2016-10634
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Report Date
    August 10, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WAS COMPLETED. THREE DEPTH GAUGES DEVICES WERE RECEIVED FOR INVESTIGATION, PART # 319.006, LOT #'S 7446554 & 7972471 AND PART # 319.004, LOT # 6923290. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE DEVICES WERE SENT TO SERVICE AND REPAIR BUT WERE UNABLE TO BE REPAIRED. UPON INSPECTION AT CUSTOMER QUALITY, THE COMPLAINT CONDITIONS WERE ABLE TO BE CONFIRMED AS EACH OF THE HOOKED NEEDLE PROBES WERE BROKEN. FOR BOTH PART # 319.006'S, THE HOOKED PROBE WAS COMPLETELY BROKEN OFF AND WAS NOT RETURNED. ONLY THE DISTAL TIP OF PART # 319.004 WAS BROKEN OFF AND NOT RETURNED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THESE DEPTH GAUGES ARE PART OF NUMEROUS TECHNIQUE GUIDES AND IS USED TO MEASURE THE DEPTH OF THE HOLES FOR THE 2.0MM/2.4MM SCREWS TO ENSURE THE CORRECT SCREW LENGTH IS USED DURING THE PROCEDURE. DRAWINGS FOR THE DEVICES WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE THICKNESS OF THE NEEDLE (1.25 MM) IS DRIVEN BY THE FACT THAT THE NEEDLE MUST FIT INTO A DRILLED HOLE OF 1.5 MM, AND THE LENGTH (80 MM) IS DETERMINED SO THE SLIDER CAN MEASURE SCREWS UP TO 40 MM. THE MATERIAL OF THE NEEDLE PROBE COMPONENT (PART # 319.004.03 AND 319.006.03) IS EXTRA HARD 316SS, WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT COMPONENT OF THIS TYPE. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A 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. THE CONDITION OF THE DEPTH GAUGES IS CONSISTENT WITH THE RESULT OF A BENDING FORCE APPLIED TO THE NEEDLE PORTION OF THE DEPTH GAUGE THAT IS BEYOND THE YIELD LIMIT OF THE MATERIAL. THERE IS A PROTECTION SLEEVE TO PROTECT THE NEEDLE DURING TRANSPORT AND THE BODY THAT SLIDES ON THE MEASURING PORTION ADDS ADDITIONAL PROTECTION TO THE NEEDLE ATTACHMENT POINT DURING USE. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS EXCESSIVE FORCE EXERTED ON THE DEPTH GAUGE BY PLACING/DROPPING HEAVY INSTRUMENTS ON TOP OF THE DEVICE DURING THE STERILIZATION PROCESS. 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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4); SUPPLIER: SYNTHES (B)(4). DATE OF MANUFACTURE/RELEASE TO WAREHOUSE DATE: AUG 8, 2013. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. A SERVICE AND REPAIR EVALUATION WAS ALSO COMPLETED FOR THE SUBJECT DEVICE. THE CUSTOMER REPORTED THE TIP BROKE OFF THE DEPTH GAUGE. THE REPAIR TECHNICIAN REPORTED "TIP BROKEN" AS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE COMPLAINT CONDITION WAS CONFIRMED. THE ITEM WILL BE FORWARDED TO SYNTHES CUSTOMER QUALITY FOR ADDITIONAL INVESTIGATION. THE RESULTS ARE PENDING COMPLETION. 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. ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 319.006 WITH LOT NUMBER (S) 7446554 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 8-AUG-2013. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. 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 THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT DURING A ROUTINE INSPECTION; THREE (3) DEPTH GAUGE TIPS WERE FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553307 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ SYNTHES MONUMENT 7446554

    Patients

    Seq Age Sex Outcome Treatment
    1