BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR F/PFNA BLADE

    MDR report key: 4974552 · Received August 5, 2015

    Report

    Report Number
    2520274-2015-15129
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. LOT NUMBER REPORTED AS CH-JPA-INS-141. THIS WAS NOT ABLE TO BE VERIFIED AS A VALID SYNTHES LOT NUMBER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A VERIFIED LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW ¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 25 AUGUST 2005. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    PRODUCT INVESTIGATION SUMMARY: THE PFNA II BLADE IS INDEED STUCK ON THE IMPACTOR AS REPORTED AND CANNOT BE REMOVED. THE GENERAL OVERVIEW SHOWS HITTING MARKS ON THE IMPACTOR AS WELL AS SOME DEFORMATION AND WEAR ON THE BLADE. 356.823 / IMPACTOR F/PFNA BLADE: THE NATURE OF THE VISIBLE HAMMERING MARKS AND STRIATIONS ON THE STRIKING HEAD, AT THE FRONT SIDE OF THE HANDLE AND EVEN ON THE SHAFT, POINT TO THE FACT THAT THE INSTRUMENT WAS SUBJECTED TO EXCESSIVE USE. THE RELEVANT DIMENSIONS COULD NOT BE VERIFIED OR FULL INSPECTION BE CONDUCTED AS IT IS IMPOSSIBLE TO DISENGAGE THE JAMMED ITEMS. THE ATTACHING AND LOCKING MECHANISM IS NOT FUNCTIONING ANYMORE; THE MECHANISM IS BLOCKED. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ACCORDING TO THE MANUFACTURING DOCUMENTATION, IT WAS PRODUCED MEETING ALL IN PROCESS AND RELEASE CRITERIA IN AUGUST, 2005. THE ROOT CAUSE IS INDETERMINABLE, BUT IT IS LIKELY THAT THE CONNECTION BETWEEN THE IMPACTOR AND THE PFNA BLADE WAS OVER TIGHTENED DURING ASSEMBLY AND/OR GOT JAMMED BECAUSE OF APPLYING EXCESSIVE WORK LOAD DURING IMPLANTING OR EXTRACTING. NO PRODUCT RELATED NONCONFORMANCE WAS DETECTED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A FEMORAL TROCHANTERIC FRACTURE OPEN SURGERY WAS CONDUCTED ON (B)(6) 2015. DURING THE SURGERY, THE REPORTED BLADE WAS NOT LOCKED AFTER THE INSERTION. IN ADDITION, THE REPORTED IMPACTOR FOR THE PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA) BLADE COULD NOT BE REMOVED FROM THE BLADE. AFTER REMOVING THE BLADE AND IMPACTOR TOGETHER, A DIFFERENT SIZED BLADE WAS INSERTED WITH THE EXTRACTION SCREW FOR PFNA BLADE. THE BLADE AND IMPACTOR REMAIN STUCK, SO THEY WILL BE RETURNED IN THE SAME STATE. THE SURGERY WAS EXTENDED FOR TWENTY (20) MINUTES. NO PATIENT HARM WAS REPORTED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514591 IMPACTOR F/PFNA BLADE IMPACTOR HWA SYNTHES BETTLACH 2154537

    Patients

    Seq Age Sex Outcome Treatment
    1