BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7711570 · Received July 23, 2018

    Report

    Report Number
    2939274-2018-53013
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Report Date
    July 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT. DATE OF EVENT IS UNKNOWN. ADDITIONAL CLASSIFICATION CODE: HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER: NON-HEALTH PROFESSIONAL--SALES REPRESENTATIVE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 314.743; SYNTHES LOT NUMBER: H220887; SUPPLIER LOT NUMBER: N/A; RELEASE TO WAREHOUSE DATE: 16-MAY-2017; EXPIRATION DATE: N/A; SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: VISUAL INSPECTION: THE DRIVE SHAFT ASSEMBLY (PART # 314.743, LOT # H220887, MFG # 16-MAY-2017) WAS RECEIVED AT US CQ WITH A BROKEN DISTAL TIP (WHICH MATES WITH THE REAMER HEAD). THE DISTAL TIP WAS BROKEN IN AN IRREGULAR MANNER RANGING FROM 4.12 MM TO 6.55 MM (CA592) DISTAL TO THE DRIVE SHAFT HELIX. PART OF THE BROKEN PORTION WAS NOT RETURNED. THE HELIX IS INTACT. FUNCTIONAL TEST: THE FUNCTIONAL INSPECTION CANNOT BE PERFORMED AT CUSTOMER QUALITY AS THE MATING DEVICE (REAMER HEAD) WAS NOT RETURNED. THE REPORTED CONDITION WAS NOT ABLE TO BE CONFIRMED BUT THE OVERALL COMPLAINT CONDITION IS CONFIRMED AS THE DISTAL TIP OF THE DRIVE SHAFT IS BROKEN. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED DUE TO POST-MANUFACTURE DAMAGE OF THE DISTAL TIP OF THE DRIVE SHAFT. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWING(S) WAS REVIEWED; DRIVE SHAFT ASSEMBLY: 314_741. NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. MATERIAL/HARDNESS REVIEW: THE MATERIAL WAS DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON THE REVIEW OF THE DHR. INVESTIGATION CONCLUSION: THE OVERALL COMPLAINT CONDITION IS CONFIRMED AS THE DISTAL TIP OF THE DRIVE SHAFT IS BROKEN. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES WHEN TRYING TO DISASSEMBLE FROM THE REAMER HEAD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STERILE PROCESSING ON (B)(6) 2018, TWO (2) REAMER HEADS WERE STUCK ON THE TWO (2) DRIVE SHAFT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553267 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.743 H220887 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1