BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 7822566 · Received August 28, 2018

    Report

    Report Number
    2939274-2018-53508
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 2, 2018
    Report Date
    August 2, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069351
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: PART: 03.010.523; LOT: 9067757; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: (B)(6) 2014 THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 50 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: COMPLAINT CONDITION: IT WAS REPORTED THAT THE TIP OF THE DRIVING CAP BROKE OFF INSIDE THE HAMMER GUIDE CONNECTOR. INVESTIGATION FLOW: BROKEN VISUAL INSPECTION: THE COMPLAINT DEVICE WAS RETURNED TO US CQ WITH THE THREADED TIP OF THE DEVICE BROKEN OFF AT THE SIXTH MOST PROXIMAL THREAD. THE BROKEN THREAD REMAINED IN THE HAMMER GUIDE CONNECTOR, WHICH WAS RETURNED AS WELL. IMPACTION MARKS WERE NOTED ON THE HEAD OF THE DRIVING CAP. MODERATE TO HEAVY SURFACE WEAR AND SCRATCHES WERE OBSERVED ON THE BULK OF THE REMAINING METALLIC SURFACES. THE BLACK FINISH ON THE CIRCULAR SURFACE THAT INTERFACES WITH THE HAMMER GUIDE CONNECTOR WAS OBSERVED TO BE PARTIALLY WORN. LIKEWISE, THE BLACK FINISH WAS WORN OFF SMALL AREAS OF THE CYLINDRICAL SECTION JUST DISTAL TO THE AFOREMENTIONED INTERFACE. THE RECEIVED CONDITION AGREES WITH THE COMPLAINT CONDITION; THUS, THE COMPLAINT IS CONFIRMED. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DOCUMENTS WERE REVIEWED AS PART OF THIS INVESTIGATION. PER PRODUCT QUALITY PLAN (PQP) FOR THE COMPLAINT DEVICE AT THE TIME OF MANUFACTURE), THE THREAD DIAMETER AT THE TIP OF THE DEVICE IS CRITICAL TO QUALITY AS IT IS PERTINENT TO FORM, FIT AND FUNCTION AND IS MEASURED VIA MICROMETER ON AN ONGOING BASIS. PER SE_515458, THE M8 THREAD DIAMETER IS 100% INSPECTED EXTERNALLY BY THE SUPPLIER AND THEN AT AN AQL OF 1 UPON INCOMING INSPECTION AT SYNTHESE, PROVIDING ASSURANCE THAT THIS CRITICAL DIMENSION IS WITHIN SPECIFICATION FOR EACH LOT OF PRODUCT. THE DESIGN CHANGES BETWEEN THE MANUFACTURED AND CURRENT DRAWING REVISIONS ARE RELATED TO THE IMPLEMENTATION OF THE UNIQUE DEVICE IDENTIFICATION ¿ DIRECT PART MARKING ON THE PRODUCT AND THE REMOVAL OF INSPECTION BUBBLES. THESE CHANGES ARE NOT RELEVANT TO THE COMPLAINT CONDITION. BASED UPON REVIEW OF THE DHR, NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURE OF THE COMPLAINT DEVICE. THE MATERIAL PROPERTIES AND HARDNESS OF THE DEVICE WERE FOUND TO BE WITHIN THE DESIGN SPECIFICATIONS. DIMENSIONAL INSPECTION: THE DIMENSION RELEVANT TO THE COMPLAINT CONDITION IS THE DIAMETER OF THE M8 THREAD AT THE DISTAL END OF THE DEVICE, WHICH BROKE. PER SE_380067, REV. K (MANUFACTURED REVISION), THE TOLERANCES ARE CONTROLLED VIA SE_022863 ¿ MK. SE_022863 LISTS W-D-S019 AS A RELATED DOCUMENT. W-D-S019 STATES THAT THE THREAD TOLERANCE CLASS SHALL BE 6G/6H UNLESS OTHERWISE SPECIFIED. AS THE THREAD TOLERANCE IS NOT EXPLICITLY CALLED OUT ON THE DESIGN DRAWING, AND AS THE THREADS IN QUESTION ARE EXTERNAL THREADS, THE 6G TOLERANCE CLASS WAS USED. ADDITIONALLY, AS NO PITCH WAS CALLED OUT ON THE M8 THREAD, THE DEFAULT PITCH (COARSE) WAS USED. PER ISO 965-2, THE MAJOR DIAMETER SPECIFICATIONS FOR A COARSE THREAD SERIES WITH 6G TOLERANCE CLASS FOR A M8 THREAD ARE Ø 7.760 MM ¿ Ø 7.972 MM (THESE TOLERANCES ARE PRIOR TO COATING; AFTER COATING, THE THREAD PROFILE SHALL NOT TRANSGRESS THE MAXIMUM MATERIAL LIMIT. WHEN MEASURED WITH A MICROMETER (OM521, CALIBRATED (B)(6) 2018 ALIBRATION DUE (B)(6) 2018) AT US CQ, THE M8 THREAD MAJOR DIAMETER MEASURED 7.921 MM. THIS VALUE IS WITHIN THE DESIGN SPECIFICATION. CONCLUSION: A VISUAL INSPECTION, DOCUMENT/SPECIFICATION REVIEW AND DIMENSIONAL INSPECTION WERE PERFORMED AS PART OF THIS INVESTIGATION. THE DISTAL TIP OF THE M8 THREAD WAS OBSERVED TO BE BROKEN AND STUCK INSIDE THE HAMMER GUIDE CONNECTOR, THUS CONFIRMING THE COMPLAINT. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED, IT IS POSSIBLE THAT AN OFF-AXIS STRIKE ON THE DRIVING CAP GENERATED EXCESSIVE SHEAR FORCES AND CONTRIBUTED TO THE COMPLAINT CONDITION. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED, AND NO NEW MALFUNCTIONS WERE IDENTIFIED EITHER. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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¿S ID AND WEIGHT WERE NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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

    IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) PROCEDURE FOR A HIP FRACTURE. DURING THE PROCEDURE, THE TIP OF THE DRIVING CAP BROKE OFF INSIDE THE THREADED HAMMER GUIDE CONNECTOR. THERE WERE NO FRAGMENTS GENERATED. ANOTHER SET OF INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TWO (2) MINUTES SURGICAL DELAY. PATIENT OUTCOME WAS REPORTED AS SUCCESSFUL. CONCOMITANT DEVICE REPORTED: HAMMER GUIDE CONNECTOR (PART #: 03.037.120, LOT #: 9761114, QUANTITY: 1). THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664397 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9067757 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR SEE EVENT DESCRIPTION