BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRAL COMBINATION HAMMER 500 GRAMS

    MDR report key: 8775390 · Received July 10, 2019

    Report

    Report Number
    2939274-2019-59091
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 13, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZY
    UDI-DI
    10886982069344
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    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 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

    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, H6: PART: 03.010.522-US; LOT: 1L59850; MANUFACTURING SITE: UMKIRCH; RELEASE TO WAREHOUSE DATE: OCTOBER 16, 2018 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SPIRAL COMBINATION HAMMER 500 GRAMS WAS RECEIVED WITH THE MALLET HEAD BROKEN OFF FROM THE HANDLE. THE FRACTURE WAS AT THE LOCATION OF THE LASER WELD BETWEEN THE HANDLE AND THE MALLET HEAD. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DOCUMENT REVIEW: DRAWINGS COMBINATION HAMMER 500 GR: HAMMERKOPF 500G SHAFT WITH SILICONE GRIP HAMMERSHAFT FURTHER DOCUMENTS PQP FOR 03.010.522 PRA FOR 03.010.522 DIMENSIONAL ANALYSIS: SHAFT WAS MEASURED OUT OF SPECIFICATION PER DRAWING. RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. CONCLUSION: 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.

    Description of Event or Problem · 0

    UPDATED. CONCOMITANT DEVICE REPORTED: UNKNOWN HIP STEM IMPLANT ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1).

    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) 2019, DURING A REVISION TOTAL HIP SURGERY, THE SPIRAL COMBINATION HAMMER WAS BROKEN. THE WELD BETWEEN THE MALLET HEAD AND THE HANDLE/SHAFT BROKE AND THE MALLET HEAD SEPARATED FROM THE MALLET SHAFT. IT STAYED ON THE SURGICAL FIELD AND DID NOT HIT ANYONE, JUST THE TABLE. IT DID NOT CAUSE ANY HARM TO THE PATIENT OR SURGICAL TEAM. THERE WAS A TWO (2) MINUTE DELAY FOR THE TEAM TO OPEN A NEW MALLET. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) SPIRAL COMBINATION HAMMER 500 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571511 SPIRAL COMBINATION HAMMER 500 GRAMS HAMMER,SURGICAL FZY WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.522 1L59850 10886982069344

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HIP STEM