BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    MDR report key: 6026838 · Received October 13, 2016

    Report

    Report Number
    2520274-2016-14899
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE JANUARY 13, 2016. NO NON-CONFORMANCE REPORTS 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 DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 ID, DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE COMPLAINED DEVICES. THE PROVIDED MANUFACTURING INVESTIGATION OF THE DRILL BITS AND DRILL SLEEVES PLUS THE PROVIDED FUNCTIONAL CHECK COULD NOT CONFIRM THE REPORTED ISSUES "THE DRILL WAS INTERFERED"/"THE DRILL DID NOT PASS THROUGH THE CONTRALATERAL CORTEX"/"HE WAS INSERTING THE SCREW, HOWEVER, HE SLIGHTLY FELT SOME KIND OF STIFFNESS"/"THE DRILL INTERFERED WITH THE NAIL". COMPLAINT UNCONFIRMED. BELOW LISTED ARTICLES ARE NOT DAMAGED AND WERE DETERMINED AS CONCOMITANT DEVICES OF THIS COMPLAINT (B)(4): 1X ART: 03.019.006 LOT: 8320027 // 1X ART. 03.019.007 LOT: 8535585, 1X ART: 03.010.063 LOT: 8780671 // 1X ART: 03.010.063 LOT: 3030267, 1X ART: 03.019.008 LOT: 8346847. TWO ARTICLES 8.0MM/3.2MM DRILL SLEEVE 200MM, PART NUMBER 03.010.064 WITH LOT 8368829 AND 8811560 WERE RETURNED AND FORWARDED TO MANUFACTURING PLANT (B)(4) FOR INVESTIGATION. THE ARTICLES ARE IN A USED CONDITION. TRACES OF USE ARE PRESENT ON THE SURFACE OF SHAFT DIAMETER. DURING MANUFACTURING INVESTIGATION, ALL RELEVANT AND SIGNIFICANT CHARACTERISTICS LIKE INNER AND OUTER DIAMETER AND THE OVERALL LENGTH WERE CHECKED. ALL MEASURED CHARACTERISTICS ARE WITHIN THE SPECIFICATION AS DEFINED ON PRODUCT DRAWING. THERE WERE NO REFERENCES TO THE REPORTED ISSUE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCTS. TWO ARTICLES 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION, PART NUMBER 03.010.060 WITH LOT 9763977 WERE RETURNED AND FORWARDED FOR MANUFACTURING INVESTIGATION. THE PRODUCTS WERE RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER MARKING WAS READABLE. TRACES OF USE WERE VISIBLE AT THE TIP FROM THE DRILL GUIDE. A DHR REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. ALL DIMENSIONS RELEVANT FOR THE FUNCTION AND THE HARDNESS OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. THE LOT OF THE RAW MATERIAL OF ARTICLE 03.010.060 IS NOT TRACKED BY NUMBER. THEREFORE THE CHECK WAS DONE BASED ON FIFO (FIRST IN/FIRST OUT) BY INVESTIGATION OF THE RAW MATERIAL ORDER, WHICH WERE CLOSEST TO THE START OF THE MANUFACTURING ORDER OF THE COMPONENT. IT WAS FOUND THAT THE USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. BASED ON THIS THE COMPLAINT IS RATED AS NOT CONFIRMED AND NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. THE PROVIDED FUNCTIONAL TEST SHOWED THAT ALL THE RETURNED ARTICLES COULD GET MOUNTED TOGETHER AND WHEN PUSHING THE DRILL BITS TROUGH THE MULTILOC¿ PROXIMAL HUMERAL NAIL Ø 8.0 MM, RIGHT, CANNULATED, LENGTH 160 MM THE FUNCTIONALLY WAS FULLY GIVEN. NO DEVIATION IN THE FUNCTIONALITY COULD BE FOUND. THE EXACT ROOT CAUSE FOR THE COMPLAINED ISSUES COULD NOT BE FOUND. THE PROVIDED FUNCTIONAL TEST SHOWED THAT THE FUNCTIONALLY WAS FULLY GIVEN. MANUFACTURING INVESTIGATION SHOWED NO DEVIATION TO SPECIFICATIONS. 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

    ADDITIONAL CONCOMITANT DEVICES REPORTED: PROTECTION SLEEVE (PART 03.010.063, LOT 3030267 AND 8780671, QUANTITY 2); INSERT-HANDLE F/MULTILOC HUM NAIL SYSTEM (PART 03.019.006, LOT 8320027, QUANTITY 1); CONNECSCR CANN F/MULTILOC HUM NAIL SYSTEM (PART 03.019.007, LOT 8535585, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT SURGERY ON PROXIMAL HUMERAL FRACTURE (THREE FRACTURE SECTIONS). THE SURGEON USED A MULTILOC HUMERAL NAIL (MULTILOC HUMERAL NAIL) 8.00MM. DURING THE SIDE-STOP DRILLING, HE TEMPORARILY FIXED THE DRILL IN A PROXIMAL HOLE. THEN HE TRIED DRILLING ON THE MOST DISTAL PORTION, BUT THE DRILL WAS INTERFERED. SO, HE TOOK OUT ONLY THE DRILL SLEEVE AND COMPLETED SCREW FIXATION. NEXT, HE REMOVED THE DRILL WHICH WAS TEMPORARILY FIXED IN THE PROXIMAL HOLE. WHEN HE TOOK THE DEPTH MEASUREMENT, HE FOUND THAT THE DRILL DID NOT PASS THROUGH THE CONTRALATERAL CORTEX. HE RE-DRILLED AND COMPLETED THE SCREW FIXATION. WHILE HE WAS INSERTING THE SCREW, HOWEVER, HE SLIGHTLY FELT SOME KIND OF STIFFNESS. AFTER THE SCREW INSERTION, HE TOOK IMAGES AND NOTICED THAT THE DRILLING WAS OFF THE TARGETED AREA. HE EXPLANTED THE SCREW AND TRIED RE-DRILLING, BUT THE DRILL INTERFERED WITH THE NAIL. HE GAVE UP FURTHER DRILLING, LEAVING THE ONLY ONE SCREW FIXED IN PLACE. WHEN THE DRILL WAS TEMPORARILY FIXED ON THE PROXIMAL SIDE, HE TOOK IMAGES AND MADE SURE THAT THE SCREW PASSED THROUGH THE NAIL. THE SURGERY WAS EXTENDED FOR 15 MINUTES. CONCOMITANT PARTS: MULTILOC PROXIMAL HUMERAL NAIL (PART: 04.016.034S, LOT: UNKNOWN, QUANTITY: 1), AIMING ARM (PART: 03.019.008, LOT: UNKNOWN, QUANTITY: 1), PROTECTION SLEEVE (PART: 03.010.063, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676628 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION BIT, DRILL HTW SYNTHES BETTLACH 9763977

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR ONE PART # 03.010.063, LOT # UNKNOWN| ONE PART # 03.019.008, LOT # UNKNOWN| ONE PART # 04.016.034S, LOT # UNKNOWN