BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIT, DRILL

    MDR report key: 6029918 · Received October 14, 2016

    Report

    Report Number
    2520274-2016-14907
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 26, 2016
    Manufacturer
    SYNTHES, USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINED DEVICE WAS NOT RETURNED FOR EVALUATION BUT THE CONCOMITANT PARTS WERE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOTS, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. NO NON-CONFORMANCE REPORTS WERE MARKED IN THE DHR DURING PRODUCTION. A MANUFACTURING EVALUATION WAS COMPLETED FOR THE CONCOMITANT PARTS: UPON FIRST INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE SHAFTS (PART 03.505.003, LOTS 8151528 AND 8141212) DO NOT FUNCTION AS INTENDED, THUS CONFIRMING THE COMPLAINT DESCRIPTION. FOR LOT 8151528 THE SMALL BALL-BEARING AT THE SPINDLE INSIDE THE INSTRUMENT IS DEFECTIVE, THE STEEL BALLS INSIDE THE BALL-BEARING ARE WORN. FURTHERMORE, NO GREASE IS VISIBLE ANYMORE AT THE INSIDE OF THE BALL-BEARING, IT SEEMS THAT THE GREASE LEAKED OUT. ALL PARTS (OUTER RING, STEEL BALLS, CAGE, INNER RING) FROM THE BALL-BEARING ARE RUSTY. FOR LOT 8141212 THE SMALL BALL-BEARING AT THE SPINDLE INSIDE THE INSTRUMENT ARE COMPLETELY WORN, THE STEEL BALLS INSIDE THE BALL-BEARING ARE COMPLETELY GONE. FURTHERMORE, NO GREASE IS VISIBLE ANYMORE AT THE INSIDE OF THE BALL-BEARING, IT SEEMS THAT THE GREASE LEAKED OUT. THE REST OF THE PARTS (OUTER RING, CAGE, INNER RING) FROM THE BALL-BEARING ARE RUSTY. FOR THE RECEIVED HANDLES (PART 03.505.004, LOTS 8142881 AND 8150163) NO INVESTIGATION WAS DONE, AS BASED ON THE INVESTIGATION FROM THE TWO RECEIVED SHAFTS THOSE ARE DEFECTIVE AND WORN. ON THIS BASIS THESE DEVICES ARE NOT RESPONSIBLE FOR THE REPORTED ISSUE. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE ADAPTOR (PART 05.001.103, SERIAL (B)(4)) IS IN OPTICAL GOOD CONDITION AND NO DAMAGE IS VISIBLE, THIS THUS NOT CONFIRMING THE COMPLAINT DESCRIPTION. AS PART OF THE MANUFACTURING INVESTIGATION A FUNCTION TEST WAS PERFORMED ON THE INSTRUMENT, WITH THE RESULTS THAT IT MEETS THE SPECIFICATIONS. THE MANUFACTURING INVESTIGATION HAS SHOWN THAT THE REPORTED FAILURE COULD NOT BE CONFIRMED AND NO FAILURE COULD BE FOUND AT THE ADAPTER. NO PRODUCT FAULT COULD BE DETECTED, AS THE ADAPTER IS WORKING AS INTENDED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT IT IS LIKELY THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE OR/AND THAT A CLEANING AND STERILIZATION ERROR LED TO THIS DAMAGE. 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

    PATIENT DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. EXACT AGE OF PATIENT REPORTED AS (B)(6). THIS REPORT IS FOR 1 UNKNOWN DRILL BIT. UDI # IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THIS REPORT IS FOR 1 UNKNOWN DRILL BIT. PMA/510(K) # IS UNKNOWN. 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.

    Description of Event or Problem · 1

    CONCOMITANT PARTS REPORTED: SHAFT FOR 90° SCREWDRIVER (PART 03.505.003, LOT 8151528, QUANTITY 1); SHAFT FOR 90° SCREWDRIVER (PART 03.505.003, LOT 8141212, QUANTITY 1); HANDLE FOR 90° SCREWDRIVER (PART 03.505.004, LOT 8142881, QUANTITY 1); HANDLE FOR 90° SCREWDRIVER (PART 03.505.004, LOT 8150163, QUANTITY 1); ADAPTOR FOR INTRA-COUPLING FOR PEN DRIVE (PART 05.001.103, SERIAL (B)(4), 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 INITIAL PROCEDURE. DURING THE PROCEDURE, WHEN DRILLING IN A 90 DEGREE ANGLE ON THE MANDIBLE BONE, THE 90 DEGREE SCREWDRIVER (SHAFT 03.505.003 ATTACHED TO THE HANDLE 03.505.004) ATTACHED TO THE AIR PEN DRIVE VIA THE ADAPTER 05.001.103 WAS USED. ONCE PIECES WERE ATTACHED TOGETHER, THE DRILL BIT TURNED NORMALLY AND WAS WORKING WHEN IT WAS OUT OF THE BONE. WHEN THE DRILL BIT TOUCHED THE BONE, IT DID NOT ENTER THE BONE AS IT SHOULD HAVE. IT STARTED FORMING A HOLE BUT THEN STOPPED TURNING AND GOT STUCK IN THE BONE. IT SEEMS THAT THE TORQUE WASN'T STRONG ENOUGH AND THE 90 DEGREE SCREWDRIVER WAS NOT DRILLING A HOLE. SINCE THE DRILL BIT GOT STUCK IN THE BONE, THE SURGEON PUT EXTRA PRESSURE ON IT TO REMOVE IT FROM THE BONE, AND THE DRILL BIT BROKE IN THE PATIENT'S MOUTH. THE SURGEON COULDN'T USE THE INSTRUMENT NEEDED. ALL BROKEN PARTS WERE RETRIEVED FROM PATIENT. NO MEDICAL INTERVENTION NEEDED. PROCEDURE SUCCESSFULLY COMPLETED. THE SURGERY WAS DELAYED FOR 30 MINUTES. REPORTEDLY, THE SURGEON TRIED TO USE ALL THE DRILL BITS THAT WERE AVAILABLE IN THE SET (DIFFERENT TYPES, REFERENCES, AND LENGTHS), BUT THE PROBLEM PERSISTED WITH ALL OF THEM. COMPARED TO WHEN THEY FIRST STARTED USING THE 90 DEGREE SCREWDRIVER, PERFORMANCE HAS DECREASED GRADUALLY WITH TIME. WHEN THEY ORDERED IT, IT USED TO DRILL VERY EFFICIENTLY, WITHOUT ANY PRESSURE, AND IN A VERY QUICK AND EASY WAY. THEN WITH TIME, THE DRILLING TOOK MORE AND MORE TIME, AND THE 90 DEGREE SCREWDRIVER SEEMED LESS AND LESS POWERFUL WHEN ENTERING INTO THE BONE. THE INCIDENT IS NOW REPORTED SINCE THE DRILL BIT NOW STOPPED TURNING INTO THE BONE, COMPLETELY, AND GOT STUCK INSIDE THE BONE. CONCOMITANT PARTS REPORTED: PART # 03.505.004 LOT # 8142881 QUANTITY: 1, PART # 03.505.004, LOT # 8150163, QUANTITY: 1, PART # 05.001.103, SER. 1311, QUANTITY: 1. THIS REPORT IS FOR (1) UNKNOWN DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682293 BIT, DRILL HTW SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR PART # 03.505.004 LOT # 8142881 QUANTITY: 1| PART # 03.505.004, LOT # 8150163, QUANTITY: 1| PART # 05.001.103, SER. (B)(4), QUANTITY: 1