BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4/2.7MM TI VA LCKNG X-PLATE SMALL-STERILE

    MDR report key: 5726301 · Received June 15, 2016

    Report

    Report Number
    3006126083-2016-10023
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 23, 2016
    Manufacturer
    SYNTHES RARON
    Product Code
    HRS
    PMA / PMN Number
    PK100776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: ARTICLE 04.211.202S, 04.211.201S AND 8 SCREWS RECEIVED. 2 PLATES AND 8 SCREWS WERE RECEIVED AND THEY ARE ALL IN A CLEAN STATE. THE PARTS SHOW MAJOR WEAR IN THE THREADS AND SOME SCRATCHES ON THE SURFACE. NO BREAKAGE DID OCCUR. 8 SCREWS ARE IN A USED CONDITION BUT NOT BROKEN APART. THE PLATE (X-PL 2.4/2.7 VA-VERRIEGELUNG KL 27*18 TA / ARTICLE # 04.211.202S / LOT # 9250353) WAS PRODUCE AS IT SHOULD. THE DEVICE-HISTORY-RECORD (DHR) DOES NOT SHOW ANY ABNORMALITIES. EVERYTHING WAS PRODUCED IN SPECIFICATION AS IT SHOULD. DUE TO THE DESTRUCTION ON THE THREADS, THE MEASUREMENTS COULD NOT BE VERIFIED ON THE COMPLAINED PART. THE PLATE (X-PL 2.4/2.7 VA-VERRIEGELUNG XS 23.5*15 / ARTICLE # 04.211.201S / LOT # 9322393) WAS PRODUCE AS IT SHOULD. THE DEVICE-HISTORY-RECORD (DHR) DOES NOT SHOW ANY ABNORMALITIES. EVERYTHING WAS PRODUCED IN SPECIFICATION AS IT SHOULD. DUE TO THE DESTRUCTION ON THE THREADS, THE MEASUREMENTS COULD NOT BE VERIFIED ON THE COMPLAINED PART. BASED ON THIS, THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. ARTICLE 03.110.005 / 2683962 AND 03.010.002 / 1000986 WERE SENT TO PLANT IN (B)(4) FOR TO PROVIDE A FUNCTIONAL CHECK: NO DEVIATION OR ANY FAILURE DETECTED. BOTH PARTS PASSED ALL INSPECTION POINTS OF SERVICE MANUAL. DEVICE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (2.4/2.7MM TI VA LCKNG X-PLATE SMALL-STERILE, PART NUMBER 04.211.202S, LOT NUMBER 9250353). THE SUBJECT DEVICE WAS RECEIVED IN A CLEAN STATE WITH NO BREAKAGE AND MAJOR THREAD WEAR. DUE TO THE DAMAGE TO THE THREADS THE MEASUREMENTS COULD NO LONGER BE VERIFIED. NO MANUFACTURING-RELATED ISSUES WERE IDENTIFIED AND THE PART WAS PRODUCED TO SPECIFICATION. THOUGH THE COMPLAINT CONDITION IS CONFIRMED, A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME, NOR WAS THE COMPLAINT CONDITION MANUFACTURING-RELATED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE IS HWC. (B)(4). (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OSTEOTOMY TO TREAT A BUNION (HALLUX VALGUS) ON (B)(6) 2016, THE VARIABLE ANGLE SCREW WAS NOT ABLE TO BE LOCKED TO THE PLATE TO AFFIX THE OPENING WEDGE. THE REPORTED ISSUE OCCURRED AS THE SURGEON ATTEMPTED TO PERFORM THE FINAL TIGHTENING USING A SCREWDRIVER WITH A TORQUE LIMITING ATTACHMENT. THE SURGEON DECIDED TO REMOVE THE PLATE FROM THE PATIENT AND HAD TO USE A SMALLER SIZED PLATE INSTEAD. THE SMALLER PLATE WAS NOT THE SURGEON'S PREFERRED IMPLANT. DURING IMPLANTATION OF THE SMALLER PLATE, A SECONDARY FRACTURE WAS GENERATED BECAUSE SCREW IN HOLE OF THE PLATE WAS CAUGHT IN THE OPERATED PART DUE TO LACK OF SIZE. THE SURGEON THUS GAVE UP FIXING THE OPENING WEDGE WITH PLATES DUE TO THE UNSECURED FIXATION. EVENTUALLY, THE SURGEON DECIDED TO USE K-WIRE TO FIX THE PLATE AFTER REMOVAL OF ALL THE IMPLANTS (THE REPORTED PLATE AND SCREWS). THE SURGERY WAS EXTENDED FOR 120 MINUTES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379839 2.4/2.7MM TI VA LCKNG X-PLATE SMALL-STERILE PLATE, FIXATION, BONE HRS SYNTHES RARON 9250353

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention PART NUMBER 04.211.022S, LOT NUMBER 9613647