BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM

    MDR report key: 6836575 · Received August 31, 2017

    Report

    Report Number
    3003875359-2017-10439
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 10, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    UDI-DI
    07611819775374
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING AND CUSTOMER QUALITY INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: ARTICLE 03.010.100 WITH LOT U258423 / DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP WAS RETURNED AND CONFIRMED FROM AFFILIATE THAT THIS IS THE COMPLAINED DRILL BIT FROM THE COMPLAINT DESCRIPTION: AS RECEIVED CONDITION OF DEVICE: DRILL BIT RECEIVED IN A SLIGHT WORN CONDITION. INVESTIGATION SUMMARY: VISUAL INCOMING INSPECTION SHOWED THAT THE DRILL BIT SURFACE DOES SHOW SMALL SCRATCHES AND DENTS BY THE CUTTING EDGES. THE SHAFT DIAMETER Ø3.2MM GOT MEASURED: INSPECTION FEATURE BASED ON SALES ORDER (B)(4) SUPPLIER ORCHID. MICROMETER: 3-03-17585 WAS USED. 1X DRILL BIT Ø3.2MM 0/-0.04MM // MEASURING RESULT: Ø3.19MM // PASS THE SPECIFICATIONS. BASED ON SALES ORDER ORCHID THE HARDENING (B)(4) WAS CHECKED WITH A RANDOM SAMPLE SURVEY AND FOUND TO BE OKAY. MATERIAL WAS CHECKED FOR CONFORMITY OF ALL 156 PIECES DELIVERED TO SYNTHES. BASED ON THE PROVIDED INVESTIGATION WE COULD NOT CONFIRM THE COMPLAINED ISSUE (WHEN THE SURGEON CHECKED THE SHAPE OF THE DRILL BIT (TIP), IT WAS NOTICED THAT THERE WAS NO SHARPNESS OF THE DRILL BIT AT THE TIP). VISUAL INSPECTION SHOWED SOME SCRATCHES AND DENTS BY THE CUTTING EDGES BUT FUNCTION OF CUTTING EDGES IS STILL GIVEN AS THEY ARE SLIGHT WORN BUT STILL SHARP AND IN WORKING CONDITION. REVIEW OF THE DHR DID NOT SHOW ANY DEVIATION AS WELL. RADIOLUCENT DRIVE WE HAVE UNFORTUNATELY NOT RECEIVED FOR INVESTIGATION. EXACT ROOT CAUSE FOR THIS COMPLAINT COULD THEREFORE NOT BE DEFINED. NO MANUFACTURING RELATED DEVIATION WAS FOUND. CONCOMITANT PART: 1X ARTICLE 03.010.100 WITH LOT U243601(DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP) WAS RATED AS CONCOMITANT DEVICE AS NO ALLEGATION WAS POINTED ON IT. NO INVESTIGATION WILL BE PROVIDED. EXACT ROOT CAUSE FOR THIS COMPLAINT COULD THEREFORE NOT BE DEFINED. 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

    MANUFACTURE DATE. DHR REVIEW WAS COMPLETED. (B)(4). MANUFACTURING DATE: 09.JAN.2017 NO NCRS 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. CORRECTED DATA: MANUFACTURE SITE. 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 INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. HOSPITAL CONTACT TELEPHONE NOT AVAILABLE FOR REPORTING. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED IN THE SURGERY FOR THE PATHOLOGICAL FRACTURE OF THE PROXIMAL HUMERUS DUE TO THE METASTATIC BONE TUMOR ON (B)(6) 2017. THE MULTILOC LONG NAIL WAS USED FOR THE PROCEDURE. AFTER PROXIMAL FIXATION WAS DONE, THE SURGEON DRILLED A HOLE FOR THE DISTAL LOCKING SCREW BY USING THE RADIOLUCENT DRIVE. THE FIRST DRILL BIT DID NOT DRILL WELL. SURGEON CHECKED THE SHAPE OF THE DRILL BIT TIP AND NOTED THERE WAS NO SHARPNESS TO THE TIP OF THE DRILL BIT. ANOTHER DRILL BIT WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY AND NOT HARM TO PATIENT. CONCOMITANT DEVICES REPORTED: MULTILOC NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); RADIOLUCENT DRIVE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613838 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM BIT, DRILL HTW SYNTHES SELZACH U258423 07611819775374

    Patients

    Seq Age Sex Outcome Treatment
    1