BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET ACE GRATER HEAD 49MM

    MDR report key: 19849909 · Received July 29, 2024

    Report

    Report Number
    1818910-2024-16149
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Report Date
    July 29, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT PRODUCT CODE: 244000549 , LOT NO - SO2052543, TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000564, LOT NO - SO20006047 TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000564, LOT NO - A0708 TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000565, LOT NO - SO2004458 TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000565, LOT NO - A0508 TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000565, LOT NO - SO2006549 TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000566 , LOT NO - SO2004077 TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000566, LOT NO - A1106 TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000566, LOT NO - SO2008186 TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000049, LOT NO - SO2043777 TRACKING NO ¿ (B)(4). HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE DEVICE FOUND WORN THAT IS CONSISTENT WITH REPETITIVE USE AND CORROSION PATTERNS BOTH INSIDE AND OUTSIDE OF OUTER SURFACE. WHERE CORROSION/OXIDATION IS IDENTIFIED AROUND THE CUTTING SURFACE OF THE DEVICE, ALONGSIDE DAMAGE CONSISTENT WITH NORMAL WEAR, THIS SUGGESTS THAT THE PASSIVE LAYER OF THE METAL HAS BEEN WORN DOWN FROM REPEATED USE (DUE TO NORMAL USE DAMAGE) ALLOWING FOR THE METALLIC SURFACE UNDERNEATH TO BECOME SUSCEPTIBLE TO CORROSION/OXIDATION. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE IN CLINICAL PRACTICE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF QUICKSET ACE GRATER HEAD WOULD HAVE CONTRIBUTED TO THE DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO AN END OF LIFE PROBLEM, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. PRODUCT CODE: 244000549 , LOT NO - SO2052543 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000564, LOT NO - SO20006047 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000564, LOT NO - A0708 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000565, LOT NO - SO2004458 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000565, LOT NO - A0508 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000565, LOT NO - SO2006549 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000566 , LOT NO - SO2004077 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000566, LOT NO - A1106 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000566, LOT NO - SO2008186 , TRACKING NO ¿ (B)(4). PRODUCT CODE: 244000049, LOT NO - SO2043777, TRACKING NO ¿ (B)(4). HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995198 QUICKSET ACE GRATER HEAD 49MM HIP INSTRUMENTS : REAMERS HTO DEPUY ORTHOPAEDICS INC US SO2043777

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown