BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 6376506 · Received March 3, 2017

    Report

    Report Number
    3000270450-2017-10072
    Event Type
    Injury
    Date Received
    March 3, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 6, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    DZI
    UDI-DI
    10887587013299
    PMA / PMN Number
    K082649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODES: HXX. A PRODUCT INVESTIGATION WAS PERFORMED. RECEIVED PART: ONE (1) SHAFT FOR 90° SCREWDRIVER (PART # 03.505.003, LOT # 8150158) WAS RECEIVED INTACT AND FULLY ASSEMBLED. THERE ARE SOME STAINS VISIBLE AT GEAR COVER, MOST LIKELY REFERABLE TO BLOOD RESIDUES. NO MECHANICAL DAMAGES COULD BE IDENTIFIED ON DEVICE'S SURFACE. THE MANUFACTURING REVIEW DOES SHOW THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UNFORTUNATELY WE CANNOT DETERMINE THE EXACT ROOT CAUSE OF THE COMPLAINED OCCURRENCE AS NO DETAILED CLINICAL INFORMATION WAS PROVIDED AND NOT ALL INVOLVED DEVICES, SUCH AS POWER DEVICE, WERE SENT BACK FOR INVESTIGATION. A FUNCTION CHECK WAS PERFORMED BY COMPLAINT HANDLING UNIT (CHU) DEPARTMENT, WHICH SHOWS THAT DRIVESHAFT IS ABLE TO BE TURNED BY HAND AND SPINS THE GEAR PROPERLY. WHEN THE DRIVESHAFT WAS REMOVED NO DAMAGES WERE OBSERVED WHICH COULD HAVE INFLUENCED FUNCTIONALITY. THIS EVALUATION HAS SHOWN THAT PRODUCT IS ACTUALLY FUNCTIONAL AS REQUIRED. BASED ON THAT FACT, THIS COMPLAINT IS RATED AS UNCONFIRMED. WE ASSUME THAT THE COMPLAINED MALFUNCTION IS MOST NEARLY REFERABLE TO A CONNECTION ISSUE BETWEEN POWER DEVICE AND INSTRUMENT. FINALLY WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED. (B)(4). 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). DEVICE HISTORY REVIEW (DHR): MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 28.MAY.2015. NO NONCONFORMANCES WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. (B)(4). 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS USED FOR JAW DEFORMITY SURGERY ON (B)(6) 2017. WHEN THE SURGEON TURNED ON THE DEVICE, UNUSUAL SOUND LIKE ¿CARACARA¿ WAS HEARD FROM THE DEVICE AND IT SEEMED LIKE THE DEVICE WAS IDLING BY ITSELF. THEN, THE TIP OF THE DEVICE GENERATED HEAT AND IT TOUCHED TO THE PATIENT¿S SOFT TISSUE AND BURNED. THE SURGEON COMMENTED THAT THE BURNED PART OF THE SOFT TISSUE WAS NOT CRITICAL PART, SO IT DIDN¿T AFFECT THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER SAME LIKE PRODUCT, AND THE SURGERY WAS COMPLETED WITHOUT CAUSING ANY DELAY. CONCOMITANT DEVICE: 1X UNK POWER DEVICE. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160903 SHAFT FOR 90° SCREWDRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH DZI SYNTHES SELZACH 8150158 10887587013299

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1 QTY UNKNOWN POWER DEVICE