BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16MM CANNULATED HOLLOW DRILL BIT

    MDR report key: 9659676 · Received February 3, 2020

    Report

    Report Number
    2939274-2020-00606
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 11, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982070203
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: E3: REPORTER IS A SYNTHES EMPLOYEE. H3, H6: PART: 03.037.004. SYNTHES LOT: 160236-201. SUPPLIER LOT: NA. RELEASE TO WAREHOUSE DATE: MARCH 13, 2017. MANUFACTURED BY SYNTHES MONUMENT. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY INVESTIGATION: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE FOLLOWING INVESTIGATION IS BASED ON THE IMAGES PROVIDED. THE IMAGES WERE REVIEWED, AND THE COMPLAINT CONDITION COULD BE CONFIRMED. AFTER REVIEWING THE IMAGES OF THE INSTRUMENT, THE HOLDING PIN OF THE SUB-COMPONENTS OF THE 16MM CANNULATED HOLLOW DRILL BIT IS BROKEN WITH REFERENCE TO THE DRAWINGS. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION AND A FUNCTIONAL TEST WERE NOT ABLE TO BE PERFORMED. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT 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 · 0

    PRODUCT COMPLAINT #(B)(4). 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART # 03.037.004 SYNTHESE LOT # 160236-201 SUPPLIER LOT # NA RELEASE TO WAREHOUSE DATE: 13 MAR 2017 MANUFACTURED BY SYNTHESE MONUMENT NO NCR'S WERE GENERATED DURING PRODUCTION.,PART # 03.037.004 SYNTHESE LOT # 160236-201 SUPPLIER LOT # NA RELEASE TO WAREHOUSE DATE: 13 MAR 2017 MANUFACTURED BY SYNTHESE MONUMENT NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.,REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: INVESTIGATION SUMMARY BACKGROUND: IT WAS REPORTED THAT ON JANUARY 8, 2020, THE CENTERING SLEEVE BECAME DAMAGED WHILE OPENING BONE FOR A TFNA. ON INSPECTION OF THE INSTRUMENT IT APPEARED THE TINY HOLDING PIN HAS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) 16MM CANNULATED HOLLOW DRILL BIT THIS COMPLAINT INVOLVES ONE (1) DEVICE. CUSTOMER QUALITY INVESTIGATION: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE FOLLOWING INVESTIGATION IS BASED ON THE IMAGES PROVIDED. THE IMAGES WERE REVIEWED, AND THE COMPLAINT CONDITION COULD BE CONFIRMED. AFTER REVIEWING THE IMAGES OF THE INSTRUMENT, THE HOLDING PIN OF THE SUB-COMPONENTS OF THE 16MM CANNULATED HOLLOW DRILL BIT (PART # 03.037.004, LOT # 160236-201) IS BROKEN WITH REFERENCE TO THE DRAWINGS. SINCE THE DEVICE WAS NOT RETURNED, DIMENSIONAL INSPECTION AND FUNCTIONAL TEST WERE NOT ABLE TO BE PERFORMED. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED.,BACKGROUND: CENTERING SLEEVE BECAME DAMAGED WHILE OPENING BONE FOR A TFNA. ON INSPECTION OF THE INSTRUMENT THIS MORNING IT APPEARS THE TINY HOLDING PIN HAS BROKEN. NO SURGERY DELAYED DUE TO THE REPORTED EVENT. AN ALTERNATIVE INSTRUMENT WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. UNKNOWN IF FRAGMENTS WAS GENERATED. THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION, NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. INVESTIGATION FLOW: DAMAGE VISUAL INSPECTION: THE 16 MM CANNULATED HOLLOW DRILL BIT (P/N: 03.037.004, LOT #: 160236-201) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE LASER WELD TO SECURE THE SPRING COMPONENT TO THE CENTERING ATTACHMENT WAS BROKEN. THE SPRING COMPONENT WAS NOT RETURNED TO US CQ. THERE WERE SCRATCHES CONSISTENT WITH DEVICE USE AND THE ETCH ON THE DEVICE STARTED TO FADE BUT HAS NO EFFECT ON THE FUNCTIONALITY OF THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE AND THE SPRING NOT RETURNED. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED COMPLAINT CONFIRMED INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE 16 MM CANNULATED HOLLOW DRILL BIT (P/N: 03.037.004, LOT #: 160236-201). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE CENTERING SLEEVE BECAME DAMAGED WHILE OPENING BONE FOR A TFNA. ON INSPECTION OF THE INSTRUMENT IT APPEARED THE TINY HOLDING PIN HAS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) 16MM CANNULATED HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121499 16MM CANNULATED HOLLOW DRILL BIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.004 160236-201 10886982070203

    Patients

    Seq Age Sex Outcome Treatment
    1