BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP F/INSERTION HANDLE

    MDR report key: 7164380 · Received January 4, 2018

    Report

    Report Number
    8030965-2018-50066
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Report Date
    December 6, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819499188
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT: IT IS UNKNOWN WHEN THE EVENT OCCURRED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. PART: 03.010.523, LOT: 8853970, MANUFACTURING SITE: (B)(6), RELEASE TO WAREHOUSE DATE: 07JUL2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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

    UPDATE TO EVENT DESCRIPTION AND CONCOMITANT DEVICES, DATE RETURNED TO MANUFACTURER, INITIAL REPORTER NAME, FACILITY NAME, ADDRESS, CITY, AND POSTAL CODE, INITIAL REPORTER OCCUPATION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE THREADED TIP OF THE DRIVING CAP IS BROKEN OFF AS COMPLAINED. IN GENERAL IS THE DEVICE IN A VERY USED CONDITION, THERE ARE NUMEROUS MARKS OF HEAVY HAMMER BLOWS ON TOP AND AS WELL AT THE EDGE OF THE HEAD. THE BROKEN FRAGMENT IS STUCK IN THE ALSO RECEIVED INSERTION HANDLE, THEREFORE AND AS THE BREAKAGE OCCURRED BELOW THE LAST THREAD FLANK THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. THUS, THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DIMENSIONS WERE WITHIN THE SPECIFICATIONS DURING THE INSPECTION. WITH STAINLESS STEEL 1.4542 THE CORRECT MATERIAL WAS USED AND THE HARDNESS WAS BETWEEN 446 AND 451 HV10, WHICH IS WITHIN THE SPECIFICATION OF 423 - 468 HV10 PER DRAWING. THE FRACTURE FACE IS HOMOGENEOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. DUE TO THE CONDITION OF THE DEVICE WE HAVE TO ASSUME THAT A MECHANICAL OVERLOAD, MOST LIKELY BY A LATERAL HIT ONTO THE EDGE OF THE HEAD, DID LEAD TO THE BREAKAGE OF THE THREADED PART. IN THIS RELATION FOLLOWING STATEMENT OF THE EXPERT LFN SURGICAL TECHNIQUE ON PAGE 23 CAN BE MENTIONED: "IF NECESSARY, USE LIGHT HAMMER BLOWS TO INSERT THE NAIL." BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 WHILST THE SURGEON WAS IMPACTING THE EXPERT LATERAL FEMORAL NAIL (LFN) THE TIP OF THE IMPACTOR/DRIVING CAP SHEARED OFF IN THE INSERTION HANDLE. CONCOMITANT REPORTED PARTS: 1X UNKNOWN LFN, 1X INSERTION HANDLE (PART 03.010.486; LOT UNKNOWN). THIS COMPLAINT INVOLVES 1 PART. THIS COMPLAINT IS FOR ONE (1) DEVICE. THIS REPORT IS FOR AN IMPACTOR/DRIVING CAP. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AS THE SURGEON WAS IMPACTING THE LATERAL ENTRY FEMORAL NAIL  EXPERT (LFN), THE THREAD BROKE OFF THE IMPACTOR WHILE IN THE INSERTION HANDLE. ALL FRAGMENTS WERE RETRIEVED. SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: LFN (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), INSERTION HANDLE (03.010.486, LOT 8628635, QUANTITY 1). THIS REPORT IS FOR ONE (1) THREADED DRIVING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7157 DRIVING CAP F/INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH OBERDORF : SYNTHES PRODUKTIONS GMBH 8853970 07611819499188

    Patients

    Seq Age Sex Outcome Treatment
    1