BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8632824 · Received May 22, 2019

    Report

    Report Number
    8030965-2019-64361
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Report Date
    April 23, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTO
    UDI-DI
    07611819739208
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DEVICE HISTORY LOT: PART NUMBER: 314.743. SYNTHES LOT NUMBER: H405472. SUPPLIER LOT NUMBER: H405472. RELEASE TO WAREHOUSE DATE: 23-FEB-2018. MANUFACTURING SITE: SYNTHES MONUMENT. SUPPLIER: CRITERION TOOL & DIE, INC. NO NCRS WERE GENERATED DURING PRODUCTION. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: DAMAGE. VISUAL INSPECTION: THE RIA DRIVE SHAFT WAS RECEIVED AT CQ WITH THE DISTAL HEXAGONAL TIP BROKEN; FRAGMENTS WERE NOT RETURNED FOR INVESTIGATION. BESIDES, THE INSTRUMENT PRESENTS NORMAL SIGNS OF USE. DIMENSIONAL INSPECTION: THE RELEVANT FEATURE IS DEFORMED IN A MANNER WHICH PREVENTS ACCURATE MEASUREMENT OF THE FEATURE. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION. SUMMARY: OUR INVESTIGATION HAS SHOWN, THAT THE REPORTED COMPLAINT CONDITION IS CONFIRMED DUE TO BROKEN TIP. BECAUSE OF THE DAMAGE, IT IS NOT POSSIBLE TO MEASURE THE RELEVANT DIMENSION. THIS DAMAGE IS CLEARLY CAUSED POST MANUFACTURING. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE DUE TO MISSING DETAILED CLINICAL INFORMATION AND MISSING BROKEN PART. WE SUPPOSE THAT A MECHANICAL OVERLOAD SITUATION DURING USE COULD LEAD TO THE BREAKAGE. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE'S. 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 · 1

    ADDITIONAL DEVICE PROCODE: HRX. INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INSPECTION, THE REAMER/IRRIGATOR/ASPIRATOR (RIA) DRIVE SHAFT WAS NOTED TO BE BROKEN AT THE EXTREMITY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RIA DRIVE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424216 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO OBERDORF SYNTHES PRODUKTIONS GMBH H405472 07611819739208

    Patients

    Seq Age Sex Outcome Treatment
    1