BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH

    MDR report key: 6106497 · Received November 16, 2016

    Report

    Report Number
    3009450863-2016-10023
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR PART # 03.211.430, LOT # 9802691. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JAN 26, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    IT WAS REPORTED THAT DURING ORIGINAL SURGERY THE SURGEON USED TWO 1.6 MM COMPRESSION WIRES 30 MM THREAD / 150 MM LENGTH TO COMPRESS PLATE TO BONE INTRA-OPERATIVELY. SURGEON USED A PAIR OF PLIERS TO COMPRESS THE WIRES AND UPON REMOVAL OF THE WIRES, ONE WIRE TIP BROKE OFF BELOW THE BALL (INSIDE THE BONE OF THE PATIENT) AND SURGEON DID NOT ATTEMPT TO RETRIEVE THE BROKEN TIP. THE SHAFT OF THE COMPRESSION WIRE IS RETRIEVED. A VISUAL INSPECTION, DIMENSIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, DHR REVIEW AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NO 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) 2016, PATIENT UNDERWENT INITIAL SURGERY (CALCANEAL OSTEOTOMY LEFT LATERAL COLUMN LENGTHENING ANKLE DEBRIBEMENT FLEXOR DIGITORUM LONGUS TENDON TRANSFER EXCISION BONE TIBIA TALUS STRAYER). DURING THE SURGERY, SURGEON USED TWO (2) 1.6 MM COMPRESSION WIRES 30 MM THREAD / 150 MM LENGTH TO COMPRESS PLATE TO BONE. THE COMPRESSION FORCEPS WAS MISSING FROM THE SET DURING SURGERY. SURGEON USED A PAIR OF PLIERS TO COMPRESS THE WIRES AND UPON REMOVAL OF THE WIRES, ONE WIRE TIP BROKE OFF BELOW THE BALL (INSIDE THE BONE OF THE PATIENT) AND SURGEON DID NOT ATTEMPT TO RETRIEVE THE BROKEN TIP. THE SHAFT OF THE COMPRESSION WIRE IS RETRIEVED. THERE WAS NO DELAY IN SURGERY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS WAS REPORTED AS STABLE. IN ADDITION TO THE REPORTED COMPRESSION WIRE, SECOND COMPRESSION WIRE WAS RECEIVED BY MANUFACTURER WITH A BENT TIP AND DAMAGED THREADS. REPORTER CONFIRMED THAT THIS MALFUNCTION DID NOT HAPPEN DURING SURGERY. CONCOMITANT MEDICAL PRODUCTS: PLIER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) COMPRESSION WIRE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756935 1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH INSTRUMENT COMPRESSION HWN SYNTHES BALSTHAL 9802691

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention ONE (1) UNKNOWN PLIER