BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L95 TAN

    MDR report key: 9239295 · Received October 25, 2019

    Report

    Report Number
    8030965-2019-69687
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    August 13, 2019
    Report Date
    August 20, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819394230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RECEIVED PFNA BLADE AND NAIL ARE JAMMED TOGETHER AS COMPLAINED. BOTH PRODUCTS SHOW SIGNS OF USE WITH SOME DEEP SCRATCHES. THE ANODIZED COLOR IS PARTLY DISAPPEARED. SUMMARY: NO MANUFACTURING RELATED ISSUES COULD BE DETECTED. THE NAIL WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. THE COMPLAINT CONDITION THAT THE BLADE IS JAMMED WITH THE NAIL CAN BE CONFIRMED. HOWEVER, IT IS CLEARLY VISIBLE THAT THE POSITION OF THE BLADE IS DISPLACED, AND CONSEQUENTLY THE REASON IS FOR THE JAMMING. WE STRONGLY ASSUME THAT THE CAUSE OF THIS COMPLAINT IS AN ALIGNMENT ISSUE DURING USE, OR NOT EXACTLY FOLLOWING THE SURGICAL TECHNIQUE STEPS. FOR MORE DETAILS REGARDING INSERTION AND EXTRACTION OF THE BLADE, PLEASE SEE IN THE CURRENT TECHNIQUE GUIDE ¿036.000.035 DSEM/TRM/0714/0109(4). WE CAN CONFIRM THE VISIBLE DAMAGES ARE NOT FROM ANY MANUFACTURING NON-CONFORMITY. THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED AND/OR USE RELATED, THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 04.027.054S, LOT: L974226, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 18 JULY 2018, EXPIRY DATE: 01 JULY 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. ADD CONCOMITANT DEVICES. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PATIENT CODE (B)(4) USED TO CAPTURE: THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT RE-OPERATION. THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE WAS STUCK IN THE PROXIMAL NAIL AND THE SURGEON COULD NOT DETACH THEM. THE NAIL HAD BEEN BROKEN AT THE POINT OF THE HOLE FOR THE BLADE AND NAIL WAS REMOVED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. AUTOGRAFT AND ALLOGRAFT WERE PERFORMED, AND RE-FIXED WITH A LONG NAIL. PATIENT CONDITION IS UNKNOWN. CONCOMITANT DEVICES: PFNA-II END CAP, PART #: 473.170S, LOT#: L608019, QUANTITY #1; LOCKING BOLT 32MM, PART #: 459.320VS, LOT#: 5943326, QUANTITY #1. THIS REPORT IS FOR 2 OF 2 FOR (B)(4). RELATED INCIDENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035875 PFNA-II BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L974226 07611819394230

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 3.9MM TI LOCKING BOLT 32MM| PFNA-II END CAP EXTENS. 0 TAN