BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSIONER

    MDR report key: 9235278 · Received October 24, 2019

    Report

    Report Number
    2939274-2019-61735
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Date of Event
    September 27, 2019
    Report Date
    September 27, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982077769
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT. PART: 03.311.001 LOT: 8401141.. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 05. JUNE 2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: INVESTIGATION SUMMARY THE RETURNED TENSIONER WAS FORWARDED TO THE MANUFACTURING SIDE FOR EVALUATION. THE STATEMENT BELOW IS A SUMMARY OF THEIR INVESTIGATION. SHIPPED BACK DEVICE ¿TENSIONER¿ 03.311.001 WITH LOT NUMBER 8401141 IS IN USED CONDITIONS. SCRATCHES ARE PRESENT ALL OVER THE DEVICE AND SIGNS OF A HEAVY USE ARE PRESENT IN PARTICULAR ON THE REACTION FORK, TOP AND LOWER PARTS. ANYWAY, THE DEVICE LOOKS LIKE ABLE TO FUNCTION. AFTER HAVING REVIEWED PQP (PRODUCT QUALITY PLAN) SE_508602, VERSION AB, AND INSPECTION SHEET SE_026728, VERSION AG VALID AT THAT TIME, FUNCTIONAL TESTS WERE PERFORMED ON THE 03.311.001 TENSIONER WITH LOT NUMBER 8401141 IN ORDER TO INVESTIGATE THE COMPLAINT. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: TENSION FORCE OF MECHANISM: FORCE MEASUREMENT 50/ 100/ 130 KG + STRETCHINESS THE WIRE USING FORCE/ PRESSURE GAUGE 60029630 WITH ID NUMBER 3276-H AND ZL FUNCTIONAL GAUGES WITH ID NUMBERS ZL-13864 AND ZL-13865-H; TIGHTEN TORQUE: REACTION FORK WITH 23 ±0.5 NM ATTRACTION USING TORQUE WRENCH WITH ID NUMBER 7812-H; HEX ON THE BACK OF THE INSTRUMENT: HEX SW 11 (0/-0.1) USING GAUGE NUMBER 50171739 WITH ID NUMBER 9719-H; ABILITY TO PENETRATE THE CENTRAL CANAL OF THE INSTRUMENT BY K-WIRE ACCORDING TO THE FUNCTIONAL AND DESIGN REQUIREMENTS: CONTINUITY USING GAUGE NUMBER 60024368 WITH ID NUMBER 11681-H. THE DEVICE PASSED ALL THE FUNCTIONAL TESTS PERFORMED. THE COMPLAINT COULD NOT BE REPLICATED WITH THE RETURNED DEVICE AND NO FUNCTIONAL ISSUE CAN BE CONFIRMED. THE FOLLOWING DOCUMENTS WERE REVIEWED: DEVICE HISTORY RECORD (DHR) 8576564; INSPECTION SHEET SE_026728 VERSION AG, ¿PA INTERN MULTIPLE 03.311.001¿; DRAWING 03_311_001_SUSA VERSION E, ¿TENSIONING DEVICE¿; DRAWING 03_311_001_23_SUSA, VERSION A, ¿TENSIONING ASSEMBLY¿; DRAWING 03_311_001_10_SUSA, VERSION B, ¿HOUSING ASSEMBLY¿; DRAWING 03_311_001_5_SUSA, VERSION C, ¿COLLECT ASSEMBLY¿; DRAWING 03_311_001_1_SUSA, VERSION C, ¿TENSIONER BODY¿. A DHR REVIEW WAS ALREADY PERFORMED AS PART OF THE OVERALL PRODUCT INVESTIGATION BY CUSTOMER QUALITY AND IT IS DOCUMENTED IN THE PRODUCT INVESTIGATION PI-15718496149576443. PART: 03.311.001. LOT: 8401141. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 05. JUNE 2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. HOWEVER, IN ORDER TO PERFORM THE INVESTIGATION, ALL THE DOCUMENTS MENTIONED ABOVE, VALID WHEN THE DEVICE WAS MANUFACTURED, HAVE BEEN ANALYZED. THE MANUFACTURING PROCESS WAS EXECUTED ACCORDING TO THE ANALYZED DOCUMENTS AND ALL CTQ (CRITICAL TO QUALITY) FEATURES WERE TESTED 100%. EVIDENCES CONFIRM THAT NO FUNCTIONAL ISSUES ARE PRESENT. FOR THIS REASON, THE COMPLAINT IS NOT CONFIRMED AND SINCE NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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. 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

    PATIENT REF. # (B)(6). 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 FOOT SURGERY, THE TWO (2) TENSIONERS WOULD NOT RELEASE REDUCTION WIRE DURING THE APPLICATION OF A DISTRACTION OSTEOGENESIS (DO) RING FIXATOR FRAME. IT CAME APART DURING THE ATTEMPTS TO RELEASE THE WIRE FROM THE TENSIONER INTRAOPERATIVELY. THERE ARE TWO TENSIONERS THAT FAILED DURING THE PROCEDURE. ANOTHER ONE (1) TENSIONER COMES TO A HARD STOP WHEN COMPLETELY RELEASING TENSION. IT IS SUPPOSED TO CLICK AND CONTINUE TO ROTATE WHEN ALL TENSION HAS BEEN RELEASED REACHING ITS ENDPOINT HOWEVER, IT DID NOT ¿CLICK¿ WHEN THE HANDLE WAS FULLY OPENED. THE SAME TYPE OF TENSIONER WAS USED TO COMPLETE THE PROCEDURE. NO ISSUE WITH WIRE. TENSIONER¿S FAILED ON BOTH REDUCTION WIRES AND SMOOTH WIRES. RIGHT LOWER EXTREMITY MULTIPLANAR RING EXTERNAL FIXATOR. WIRE DID NOT APPEAR TO BE THE ISSUE. TENSIONER MALFUNCTION OCCURRED ON SEVERAL DIFFERENT WIRES. TWO OF THE TENSIONERS TERMINALLY IMPINGED ON THE WIRE. IN AN EFFORT TO RELEASE THE TENSIONER FROM THE WIRE THE PHYSICIAN CONTINUED TO TURN THE HANDLE COUNTER CLOCKWISE. TWO OF THE TENSIONERS BECAME DISASSEMBLED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN RING FIXATOR FRAME (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029523 TENSIONER MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.311.001 8401141 10886982077769

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR UNK - DO RINGS