BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    MDR report key: 7814007 · Received August 24, 2018

    Report

    Report Number
    2939274-2018-53462
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Report Date
    June 25, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982201386
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 398.41, LOT# T122262. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: OCT 27, 2015. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND ITS SUB COMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. A REVIEW OF THE DHR AND MANUFACTURING RECORDS CONFIRMED THAT THE CORRECT MATERIAL(S) WERE USED TO MANUFACTURE THE DEVICE. A REVIEW OF THE DHR AND THE HARDNESS MANUFACTURING RECORDS CONFIRMED THAT THE HARDNESS OF THE DEVICE FELL WITHIN SPECIFICATION WHEN MANUFACTURED. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. VISUAL INSPECTION OF THE RETURNED BROAD REDUCTION FORCEPS (FORCEPS) REVEALED NO DAMAGE TO THE RATCHETING TEETH. THE TEETH OF BOTH TIPS THAT INTERFACE WITH THE BONE WERE WORN. ONE TIP WAS BENT IN A WAY THAT IT WAS SLIGHTLY OUT OF ALIGNMENT WITH THE OTHER TIP. THIS TIP WAS ALSO NICKED. A VERY SMALL SECTION OF THE MOST DISTAL PORTION OF THE SECOND TIP HAD BROKEN OFF. THE FORCEPS WERE ABLE TO HOLD AT ALL POSITIONS. THE FORCEPS DEMONSTRATED MILD RESISTANCE WHILE OPENING AND CLOSING. FURTHER TESTING OF THE FORCEPS¿ DISTAL TIP FUNCTION OF REDUCING BONE FRACTURES COULD NOT BE PERFORMED AT CUSTOMER QUALITY (CQ). HOWEVER, IT IS POSSIBLE THAT THE DAMAGE NOTED IN THE VISUAL INSPECTION SECTION COULD IMPACT THE FORCEPS ABILITY TO SECURE BONE FRAGMENTS DURING REDUCTION. THE COMPLAINT CONDITION COULD NOT BE DUPLICATED AT CQ; HOWEVER, A FUNCTIONAL ISSUE COULD NOT BE RULED OUT DUE TO THE RELEVANT VISUAL DAMAGE TO THE DISTAL TIPS. THE COMPLAINT IS CONFIRMED. DIMENSION INSPECTION OF THE RETURNED DEVICE REVEALED THE GAP BETWEEN THE DISTAL TIPS WAS 1.05MM, WHICH WAS WITHIN SPECIFICATION OF 1MM +0.5/-0 PER DRAWING. MEASURED USING CA215. A RELEVANT DRAWING WAS REVIEWED DURING INVESTIGATION. DURING THE INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION WAS CONFIRMED DURING INVESTIGATION, AS VISUAL INSPECTION REVEALED DAMAGE RELEVANT TO THE COMPLAINT CONDITION. THE RETURNED CONDITION OF THE DEVICE INDICATES THE FORCEPS MAY HAVE EXPERIENCED ROUGH HANDLING AND ABNORMAL FORCES DURING USE AND HANDLING. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 A ROUTINE INSPECTION ON (B)(6) 2018, IT WAS FOUND THAT ONE (1) BROAD REDUCTION FORCEPS WON'T HOLD. THERE IS NO PATIENT INVOLVEMENT. THE FORCEPS WAS FOUND TO BE BROKEN DURING INVESTIGATION AT THE MANUFACTURER. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS BROAD-RATCHET. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654386 REDUCTION FORCEPS WITH POINTS BROAD-RATCHET FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC T122262 10886982201386

    Patients

    Seq Age Sex Outcome Treatment
    1