BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 11771823 · Received May 4, 2021

    Report

    Report Number
    8030965-2021-03554
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    January 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    UDI-DI
    07611819933330
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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. H3, H4, H6: PART: 03.617.993. LOT: 8003212. MANUFACTURING SITE: HAGENDORF. RELEASE TO WAREHOUSE DATE: AUGUST 29, 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE COMPLAINT DEVICE AWL Ø2 ANGL WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. DURING VISUAL INSPECTION, NO ISSUES WERE IDENTIFIED ON THE DEVICE. DOCUMENT /SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF DRAWINGS. FOR THE PART WERE REVIEWED: AWL 40° ANGLED COMPLETE AND TIP. DIMENSIONAL INSPECTION: MEASURED DIMENSION: DIAMETER OF THE TIP: CONFORMING. CONCLUSION: THE RETURNED DEVICE HAD NO DEFECT THAT COULD HAVE RESULTED IN THE COMPLAINT. HENCE, THE COMPLAINT WAS NOT CONFIRMED. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 · 0

    PRODUCT COMPLAINT # (B)(4). EVENT YEAR IS REPORTED AS 2021; HOWEVER EXACT DATE OF EVENT IS UNKNOWN. ADDITIONAL PRODUCT CODE : OVE. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHEN USING THE AWL FOR THE SCREW HOLE IN THE PATIENT, THE SURGEON PULLED OUT THE AWL AND THE SHARP TIP OF THE AWL WAS STILL IN THE SCREW HOLE. THE SURGEON USED FORCEPS TO PULL OUT THE AWL TIP. THERE WAS NO DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ZERO PROFILE SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.0MM ANGLED AWL THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666024 2.0MM ANGLED AWL APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES GMBH 8003212 07611819933330

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWS: ZERO-P