BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 6824729 · Received August 28, 2017

    Report

    Report Number
    1719045-2017-10847
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 7, 2017
    Report Date
    August 7, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA, PART NUMBER 314.743, LOT NUMBER H220887). FOLLOWING DEVICE WAS RETURNED UNDER (B)(4); DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA (PN 314.743, SYNTHES LOT# H220887) THE RETURNED INSTRUMENT WAS EXAMINED AT CUSTOMER QUALITY AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED. A VISUAL INSPECTION, DEVICE HISTORY RECORDS REVIEW, DRAWING REVIEW AND DIMENSIONAL VERIFICATION OF THE RELEVANT DEVICE FEATURES WERE PERFORMED AS PART OF THIS INVESTIGATION. A FUNCTIONAL TEST OR COMPLAINT REPLICATION IS NOT APPLICABLE AS THE DAMAGE WAS VISUALLY CONFIRMED. NO NEW MALFUNCTIONS WERE IDENTIFIED DURING THE INVESTIGATION. RIA DRIVE SHAFT (PART #314.743) IS USED UNDER THE INTRAMEDULLARY REAMING AND BONE HARVESTING. IT IS IMPLEMENTED FOR AUTOGENOUS BONE HARVESTING AND REMOVING INFECTED AND NECROTIC BONE AND TISSUE FROM THE INTRAMEDULLARY CANAL. THE RIA DRIVE SHAFT (PART #314.743) WAS RETURNED WITH THE BROKEN/MISSING TIP LEAVING THE DISTAL END OF THE INSTRUMENT SHAFT IN THE JAGGED FORM. THE HELIX OF THE SHAFT IS INTACT. THE BROKEN FRAGMENT WAS NOT RETURNED WITH THE COMPLAINT. THERE ARE FEW SUPERFICIAL STRIATION MARKS OVER THE SURFACE OF THE SHAFT, WHICH DO NOT IMPACT FUNCTIONALITY. THERE ARE SOME WEAR MARKS AND MINOR INDENTATIONS NEAR THE COUPLING END OF THE SHAFT. RELEVANT PRODUCT DRAWINGS WERE REVIEWED: DRIVE SHAFT ASSEMBLY DRAWING 314_741 AND DRIVE SHAFT HELIX 314_741 _13. PORTION OF THE DISTAL TIP, APPROX. 13 MM IN LENGTH, IS MISSING. FEATURES OF THE DISTAL TIP, ESPECIALLY ACROSS THE FLAT LENGTHS COULD NOT BE MEASURED DUE TO BROKEN TIP. OD OF THE HELIX MEASURED WITHIN THE SPECIFICATION AT 5.96 MM (SPEC: 6 MM +/-0.1 PER DWG. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. CALIPERS USED ¿ CA30. IT IS POSSIBLE THAT THE TIP OF THE SLEEVE AND THE REAMER HEAD WERE DAMAGED DUE TO EXCESSIVE TORQUE OR OFF-AXIS FORCE APPLIED ON THE DEVICE. THE PATIENT BONE QUALITY, INCORRECT TECHNIQUE MAY HAVE ALSO CONTRIBUTED TO THE COMPLAINT CONDITION. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED IN THE ABSENCE OF ADDITIONAL DETAILS ABOUT THE COMPLAINT INCIDENT. 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 WEIGHT IS NOT PROVIDED FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE: HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART# 314.743, SYNTHES LOT# H220887: RELEASE TO WAREHOUSE DATE: 16-MAY-2017, 05-JUN-2017, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NON-CONFORMANCE REPORT (NR) WAS GENERATED FOR 2 PARTS OF 35 BEING BELOW THE LOWER SPEC LIMIT DURING PRODUCTION. THESE 2 PARTS WERE RETURNED TO THE SUPPLIER FOR EVALUATION AND REWORK, IF FEASIBLE. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE HAS BEEN 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION OF A 12X360 TIBIAL NAIL EX AND THREE 5MM LOCKING SCREWS ON (B)(6) 2017 DUE TO INFECTION FOUR MONTHS AFTER DEVICES WERE IMPLANTED. THE ABSCESS INFECTION WAS EXPLORED AND WASHED OUT. A 9MM X 360 MM NAIL COATED PALACOS CEMENT WITH VANCOMYCIN ADDRESS WAS INSERTED AND LOCKED WITH ONE 4MM X 48MM SCREW PROXIMALLY AND ONE 4MM X 38MM SCREW DISTALLY. DURING THE REVISION PROCEDURE, THE REAMER IRRIGATOR ASPIRATOR (RIA) 14.0 MM REAMER HEAD FOR RIA BROKE WHILE REAMING. THE RIA DRIVE SHAFT ALSO BROKE AT THE TIP WHERE IT INSERTS INTO THE REAMER HEAD. RIA REAMING WAS DISCONTINUED. ALL INTRAMEDULLARY FRAGMENTS OF THE REAMER HEAD APPEARED TO BE RETRIEVED ON X-RAY. THE SURGEON THEN SWITCHED TO CONVENTIONAL REAMING UP TO 14 MM. THERE WAS REPORTEDLY A FORTY-FIVE (45) MINUTE SURGICAL DELAY. PATIENT¿S OUTCOME IS UNKNOWN. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: LOCKING CLIP (PART # 352.260S, LOT # H330488, QUANTITY 1); RIA TUBE ASSEMBLY (PART # 314.746S, LOT # H223161, QUANTITY 1); DRIVE SHAFT SEAL (PART # 351.718S, LOT # H407754, QUANTITY 1). THE POSTOPERATIVE ISSUE OF INFECTION HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT ADDRESSES INTRAOPERATIVE ISSUES WHICH OCCURRED DURING REVISION SURGERY. THIS REPORT IS FOR ONE (1) DRIVE SHAFT FOR USE WITH RIA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605239 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 314.743 H220887 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR