BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM CANNULATED DRILL BIT LARGE QC/190MM

    MDR report key: 3647885 · Received February 26, 2014

    Report

    Report Number
    1719045-2014-00122
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    February 2, 2014
    Report Date
    February 2, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRECISION EDGE SURGICAL PRODUCTS COMPANY LLC MANUFACTURED THE 12MM CANNULATED DRILL WITH LARGE QUICK COUPLING, P/N 03.010.036, AND LOT NUMBER PE01968. THE COMPLAINT CONDITION (CHUCK PORTION OF DRILL BIT SNAPPED) IS DUE TO AN UNKNOWN CAUSE. THE LOT INITIALLY CONFORMED TO ALL REQUIREMENTS PER THE CERTIFICATE OF COMPLIANCE AND WAS INSPECTED / CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4). BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. MFR DATE: ADDITIONAL WAREHOUSE RELEASE DATE 1/14/14.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR DIAGNOSIS, NOT TREATMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED. PRECISION EDGE SURGICAL PRODUCTS MANUFACTURED THE 12.0MM CANNULATED DRILL BIT LARGE QC/190MM, P/N 03.010.036, AND LOT NUMBER PE01968 FOR POS (B)(4) AND (B)(4). THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED 11/19/13 FOR BOTH SYNTHES LOTS) INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.010.036, AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) (DATED 11/22/13 AND 1/13/14 FOR THE TWO RECEIPTS OF THIS LOT). THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. THE PARTS WERE RELEASED 11/25/13 AND 1/14/14. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED. ONE 12.0MM CANNULATED DRILL BIT LARGE QC/190MM WAS RETURNED WITH A COMPLAINT CATEGORY OF ¿BROKE DURING INSERTION/REMOVAL.¿ THE 12.0MM CANNULATED DRILL BIT LARGE QC/190MM IS PART OF THE TIBIAL NAIL ¿ EX INSTRUMENT SET (01.116.040) AND IS USED TO OPEN UP THE MEDULLARY CAVITY OF THE TIBIA PRIOR TO IMPLANTATION OF A CANNULATED TIBIA NAIL. FROM THE TIBIAL NAIL-EX IMPLANT SET. THE INFORMATION IS PROVIDED PER THE TITANIUM CANNULATED TIBIAL NAILS TECHNIQUE GUIDE J11965-C. THE RETURNED 12.0MM CANNULATED DRILL BIT LARGE QC/190MM (LOT# PE01968) WAS MANUFACTURED IN (B)(4) ON 11/13 AND IS LESS THAN A YEAR OLD AND SHOWS NO EVIDENCE OF MISUSE. PER THE TECHNIQUE GUIDE, THE 12.0MM CANNULATED DRILL BIT LARGE QC/190MM IS INSERTED OVER A GUIDE WIRE THROUGH A PROTECTION SLEEVE. A REVIEW OF THE MOST CURRENT REVISION OF THE DESIGN DRAWINGS (03.010.036 REVISION E) WAS PERFORMED AND THERE WERE NO CHANGES MADE TO THE DESIGN OF THE 12.0MM CANNULATED DRILL BIT LARGE QC/190MM. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. BECAUSE ONLY HALF OF THE INSTRUMENT WAS RETURNED THE CHU ENGINEER WAS UNABLE TO ASCERTAIN THE CAUSE OF THIS COMPLAINT CONDITION, THIS COMPLAINT IS INDETERMINATE FROM A DESIGN PERSPECTIVE. PER THE RISK ANALYSIS THE ESTIMATED OCCURRENCE RATE IS (B)(4). THEREFORE, THIS PART # 03.010.036 WITH THIS TYPE OF ERROR IS ASSESSED AS A LESS SEVERE RISK WITH A MODERATE SEVERITY OF HARM ¿3¿ AND AN UNLIKELY PROBABILITY OF OCCURRENCE OF UNLIKELY PROBABILITY OF OCCURRENCE OF ¿2¿WITH THE POSSIBLE HARM LISTED AS SIGNIFICANT PROLONGATION OF SURGERY. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE 12.0MM CANNULATED DRILL BIT LARGE QC/190MM SHOWS NO EVIDENCE OF MISUSE, BUT ONLY HALF THE INSTRUMENT WAS RETURNED TO THE CHU. THEREFORE, THIS COMPLAINT WAS UNABLE TO BE VERIFIED. THEREFORE PART# 03.010.036 IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE WHEN USED AS RECOMMENDED; AND THIS COMPLAINT IS INDETERMINATE FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIAL NAILING PROCEDURE, THE DRILL BIT BROKE AT THE CONNECTION POINT AT THE CHUCK, SNAPPED AND BECAME UNUSABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DRILL BIT AVAILABLE. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A DELAY OF 2-3 MINUTES. THERE WERE NO BROKEN FRAGMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117838 12.0MM CANNULATED DRILL BIT LARGE QC/190MM BIT,DRILL HTW SYNTHES MONUMENT PE01968

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR