BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.5 L110/85 2FLUTE

    MDR report key: 6312984 · Received February 8, 2017

    Report

    Report Number
    9612488-2017-10051
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 17, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWE
    UDI-DI
    07611819018631
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODES: GFF, GFA, HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. PART# 310.250 / LOT 9920362; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 03.MAY.2016. 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. 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

    (B)(6). PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED FOR PART# 310.250, LOT# 9920362. A VISUAL INSPECTION, DEVICE HISTORY RECORDS REVIEW AND FUNCTIONAL TEST WAS DONE AS PART OF THIS INVESTIGATION. MEASURING OF RELEVANT DIAMETER WITH MEASURING TOOL SHOWS 2.49MM WHAT MEETS TO THE SPECIFICATIONS. FUNCTIONAL TEST SHOWS THAT THE DRILL BIT CAN BE PASSED THROUGH THE DOUBLE DRILL GUIDE AS INTENDED. HOWEVER, VISIBLE SCRATCHES AT THE SHAFT OF THE DRILL BIT INDICATE STRONG CONTACT OF THE DRILL BIT WITH OTHER METALLIC PARTS. WE HAVE TO ASSUME THAT RESIDUES OF THE BONE INSIDE THE TUBE OF THE DRILL GUIDE LED TO BLOCKAGE OF THE PARTS. NO PRODUCT PROBLEM COULD BE IDENTIFIED. 1X 312.280 / 9835153 (DOUBLEDRILLGUIDE 3.5/2.5) DEVICE WAS INITIALLY REPORTED AS CONCOMITANT DEVICE. THE DEVICE WAS ADDED AND ASSESSED AS REPORTABLE PART. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED DEVICES WERE USED IN SURGERY FOR DISTAL CLAVICLE FRACTURE ON (B)(6) 2017. LCP-CHP (LOCKING COMPRESSION PLATE CLAVICLE HOOK PLATE) WAS USED. AFTER THE SURGEON SET THE PLATE, HE DRILLED WITH A DRILL BIT AND A DOUBLE DRILL GUIDE, HOWEVER, HE COULDN¿T DRILL SMOOTHLY SO HE TRIED TO PULL THE DRILL BIT OUT. THE SURGEON COULDN¿T PULL THE DRILL BIT OUT OF THE DOUBLE DRILL GUIDE SO HE EXTRACTED IT WITH A PLIER. HE DIDN¿T USE CORTEX SCREWS, HE ONLY USED LOCKING SCREWS AND COMPLETED THE SURGERY. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT AND SURGICAL OUTCOME. THERE WAS A SURGICAL PROLONGATION OF 10 MINUTES REPORTED. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT DEVICES: 1X 312.280 / 9835153 (DOUBLEDRILL GUIDE 3.5/2.5); 1X UNK LCP-CHP PLATE; 1X UNK PLIER; UNK CORTEX SCREWS (QUANTITY UNK); UNK LOCKING SCREWS (QUANTITY UNK). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    NO OTHER MEDICAL INTERVENTION WAS REQUIRED. CONCOMITANT MEDICAL PRODUCTS: 1X UNK LCP-CHP PLATE; 1X UNK PLIER; UNK CORTEX SCREWS (QUANTITY UNK); UNK LOCKING SCREWS (QUANTITY UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93839 DRILL BIT Ø2.5 L110/85 2FLUTE INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES BETTLACH 9920362 07611819018631

    Patients

    Seq Age Sex Outcome Treatment
    1 1X 312.280 / 9835153 (DOUBLEDRILLGUIDE 3.5/2.5)| 1X UNK LCP-CHP PLATE| 1X UNK PLIER| UNK CORTEX SCREWS (QUANTITY UNK)| UNK LOCKING SCREWS (QUANTITY UNK)