BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM DRILL BIT/QC/100MM

    MDR report key: 6371715 · Received March 2, 2017

    Report

    Report Number
    9612488-2017-10082
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 6, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWE
    UDI-DI
    07611819018587
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (2.0MM DRILL BIT/QC/100MM, PART NUMBER 310.190, LOT NUMBER 2113785). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: OUR INVESTIGATION SHOWS THAT RECEIVED DRILL BIT IS BROKEN AS DESCRIBED IN COMPLAINT CONDITION. BASED ON THIS FACT THIS COMPLAINT IS RATED AS CONFIRMED. FURTHERMORE, WE FOUND CUTTING EDGES BLUNT, STRIATIONS SIGNS ON DRILL BIT'S SURFACE AND SEVERAL NICKS ALONG THE FLUTE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UNFORTUNATELY, WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT CONFIRM HOW THE BREAKAGE HAPPENED. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE, WITH MAGNIFICATION OF 10X, SHOWS A HOMOGENOUS SURFACE WHAT INDICATES MATERIAL CONFORMITY. WE SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE ARTICLE 310.190 WITH LOT NO 2113785 WAS MANUFACTURED IN A QUANTITY OF (B)(4) PIECES ON FEB. 2005. WE ARE NOT AWARE OF ANY QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT ON THE ARTICLE. ALSO, WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION. AT THIS POINT, WE WANT TO BRING UP OUR RECOMMENDATIONS IN OUR LEAFLEAT, WHICH DESCRIBES THE END OF LIFE OF AN INSTRUMENTS AT PAGE 4: "END OF LIFE OF A DEVICE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. EVIDENCE OF DAMAGE AND WEAR ON A DEVICE MAY INCLUDE BUT IS NOT LIMITED TO CORROSION (I.E. RUST, PITTING), DISCOLORATION, EXCESSIVE SCRATCHES, FLAKING, WEAR AND CRACKS. IMPROPERLY FUNCTIONING DEVICES, DEVICES WITH UNRECOGNIZABLE MARKINGS, MISSING OR REMOVED (BUFFED OFF) PART NUMBERS, DAMAGED AND EXCESSIVELY WORN DEVICES SHOULD NOT BE USED." FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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 ID, DATE OF BIRTH AND WEIGHT WERE NOT PROVIDED FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODES: GFF, GFA, HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 310.190, LOT# 2113785. MANUFACTURING LOCATION: (B)(4) MANUFACTURING DATE: FEB 03, 2005. 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. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT SURGERY FOR DISTAL RADIUS FRACTURE. DURING THE PROCEDURE, AS TEMPORAL TRACKING, THE SURGEON INSERTED A DRILL BIT 1.8 MM. INSERTING A CORTICAL SCREW 2.7 MM, HE DRILLED MAKING SOME ANGLE TO PREVENT A DRILL BIT 2.0 MM FROM GOING TO THE TEMPORAL TRACKING HOLE. THE 2.0 MM DRILL BIT BROKE AND THE BROKEN PART WAS LEFT INSIDE THE PATIENT. THE SURGEON EXTRACTED THE DRILL BIT FROM DORSAL. THE SURGEON COMMENTED THAT SINCE HE INSERTED MAKING SOME ANGLE, THE DRILL BIT HAD TO BEAR A BURDEN. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS A SURGICAL PROLONGATION OF 20 MINUTES REPORTED. PATIENT OUTCOME WAS REPORTED AS HAVING NO EFFECT. CONCOMITANT DEVICES REPORTED: CORTICAL SCREW 2.7 MM (QUANTITY 1), DRILL BIT 1.8 MM (QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.0 MM DRILL BIT/QC/100 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156650 2.0MM DRILL BIT/QC/100MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS&ATTACH HWE SYNTHES BETTLACH 2113785 07611819018587

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ONE (1) UNKNOWN CORTICAL SCREW 2.7MM| ONE (1) UNKNOWN DRILL BIT 1.8MM