BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM

    MDR report key: 8151705 · Received December 11, 2018

    Report

    Report Number
    2939274-2018-55350
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 20, 2018
    Report Date
    November 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982203052
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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: 399.78, SYNTHES LOT NUMBER: T924776, RELEASE TO WAREHOUSE DATE: 22-AUG-2008, MANUFACTURE SITE: TUTTLINGEN, PART EXPIRATION DATE: N/A, LIST OF NONCONFORMANCE¿S: N/A. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND IT'S SUB COMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. TRACEABILTY TO THE RAW MATERIAL LOT NUMBER COULD NOT BE ESTABLISHED DURING THIS DHR REVIEW. NO NCRS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. REVIEW OF THE DEVICE HISTORY RECORD OF TUTTLINGEN SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY CONFIRMED THE CONDITION OF DEVICE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE RIGHT FORCEPS TONG COMPONENT HAS BROKEN AT AN OBLIQUE ANGLE JUST DISTAL TO THE PIVOT SCREW. THE BROKEN OFF PORTION OF THE DEVICE WAS RETURNED. NO FURTHER ISSUES WERE NOTED. DOCUMENT/SPECIFICATION REVIEW: THE RETURNED DEVICE WAS MANUFACTURED IN 22-AUG-2008 AND IS OVER 10 YEARS OLD. A REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. TRACEABILITY TO THE RAW MATERIAL LOT NUMBER COULD NOT BE ESTABLISHED DURING THIS DHR REVIEW. HOWEVER, THE MATERIAL SURFACE AT THE FRACTURE SITE APPEARS HOMOGENEOUS WITH NO VOIDS OR ABNORMALITIES WHEN VIEWED UNDER MAGNIFICATION. NO NCRS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. DIMENSIONAL INSPECTION: THE THICKNESS OF THE RIGHT FORCEPS TONG NEAR LOCATION OF BREAKAGE MEASURED 6.23 MM WHICH IS WITHIN SPECIFICATION CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE 10 YEAR OLD REUSABLE INSTRUMENT BREAKING COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE MOST LIKELY POTENTIAL CAUSES ARE CUMULATIVE WEAR, ROUGH HANDLING OR APPLICATION OF EXCESSIVE LEVERAGE. THE OBLIQUE FRACTURE ANGLE DOES SUGGEST EXCESSIVE LEVERAGE WAS APPLIED. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, THE LARGE POINTED REDUCTION FORCEPS BROKE WHILE ATTEMPTING TO REDUCE A PUBIC SYMPHYSIS DISRUPTION. THE BROKEN PART WAS RETRIEVED AND THE SURGERY CONTINUED WITHOUT DELAY. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992041 REDUCTION FORCEPS WITH POINTS SPEED LOCK 205MM FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 399.78 T924776 10886982203052

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR