BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 TIBIAL RADEL IMPACTOR

    MDR report key: 14250251 · Received April 29, 2022

    Report

    Report Number
    1818910-2022-07863
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 29, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWA
    UDI-DI
    10603295147916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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: NO DEVICE WAS RECEIVED FOR EXAMINATION. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS, THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED. AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE) WAS NOT POSSIBLE, BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: B5 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    INSTRUMENTS ARE BROKEN DUE TO WEAR AND TEAR. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIBIAL RADEL IMPACTOR HAD SPLIT, BUT WAS STILL INTACT AND WAS NOT USED AGAIN ON A PATIENT. NO ITEMS HAD BROKEN INTO MORE THAN ONE PIECE.

    Description of Event or Problem · 0

    A. PLEASE PROVIDE THE LOT NO OF THE FOLLOWING PRODUCTS: *SP*2 FEMORAL IMPACTOR (966180) *SP2 TIBIAL RADEL IMPACTOR (258111000) *PFCSIG POSTLIP TRIAL 8MM SZ5 (961260) *PFCSIGMA INS TRL STABL 8MM SZ4 (961450) I¿VE CHECKED ALLL OF THESE COMPONENTS, THERE ARE NO VISIBLE LOT NUMBERS WHICH I CAN SEE, B. WHICH PART OF THE INSTRUMENTS WERE BROKE? SP*2 FEMORAL IMPACTOR (966180) , THIS IS LOOSE , AND NO LONGER ABLE TO BE SCREWED BACK TIGHT, (IT¿S IN TWO PARTS) *SP2 TIBIAL RADEL IMPACTOR (258111000), THIS HAS SPLIT, BUT IS STILL INTACT, NPBUT NOT ABLE TO BE USED AGAIN ON A PATIENT *PFCSIG POSTLIP TRIAL 8MM SZ5 (961260) THIS IS SPLIT, AT THE BACK OF THE TRIAL, *PFCSIGMA INS TRL STABL 8MM SZ4 (961450) ANOTHER SPLIT TRIAL, IN ONE PIECE , AT THE BACK WHERE IT SITS INTO A TRIAL TIBIAL TRAY. C. DID THEY BROKE INTO 2 OR MORE PIECES? NO ITEMS HAD BROKEN INTO MORE THAN ONE PIECE . PLEASE ALSO PROVIDE US WITH AN UPDATE WITH REGARDS TO THE PRODUCT RETURN. HAVE YOU ALREADY RETURNED THE PRODUCT FOR ANALYSIS? (IF YES, PLEASE CONFIRM THE DATE SHIPPED AND THE COURIER TRACKING NUMBER). IF THE HOSPITAL HAS NOT OR WILL NOT RELEASE THE PRODUCT UNTIL A FUTURE DATE PLEASE CONFIRM THIS AND WHAT THE FUTURE DATE IS. IF THE PRODUCT IS NO LONGER AVAILABLE PLEASE ADVISE. THE HOSPITAL HAS DISCARDED THE ITEMS, THEY ARE NO LONGER AVAILABLE TO RETURN TO THE ANALYSIS LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213848 SP2 TIBIAL RADEL IMPACTOR KNEE INSTRUMENT : IMPACTORS HWA DEPUY ORTHOPAEDICS INC US 2581-11-000 10603295147916

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown