BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 5982267 · Received September 27, 2016

    Report

    Report Number
    2530088-2016-10270
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 8, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. MATERIAL REVIEW REPORT WAS ISSUED FOR 50 DEVICES, LOT # 4984114 FOR MISSING ETCH (CE AFTER LOT #). REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. DATE OF ORIGINAL REPORT WAS SEPTEMBER 8, 2016, NOT SEPTEMBER 7, 2016 AS ORIGINALLY REPORTED. 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 PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES. TWO (2) STANDARD INSERTION HANDLES (PART 03.010.045, LOTS 4984114 (MFG. 20-JUL-2005) AND 4984116 (MFG. 21-NOV-2005) WERE RETURNED WITH A COMPLAINT STATING THAT ONE WAS MISSING THE TAB THAT PREVENTS THE NAIL FROM ROTATING (LOT 4984116) AND THE OTHER WOULD NOT ACCEPT THE PROTECTION SLEEVE IN THE ANTEGRADE HOLE. THERE WAS A 60 MINUTE SURGICAL DELAY SINCE ANOTHER INSERTION HANDLE HAD TO BE LOCATED. THE COMPLAINT WAS ABLE TO BE CONFIRMED. BOTH HANDLES WERE RETURNED IN EXTREMELY WORN CONDITIONS WITH SCRATCHES AND WEAR MARKS EVIDENT THROUGHOUT THE DEVICES. SIGNIFICANT IMPACT MARKS WERE APPARENT ON THE INFERIOR END OF THE OBLIQUE HOLE OF THE 4984114 HANDLE WHICH LIKELY RESULTED IN THE COMPLAINT CONDITION. A KNOWN GOOD PROTECTION SLEEVE (PART 03.010.063 LOT 7586191) WOULD NOT PASS THROUGH THE ANTEGRADE HOLE OF THE HANDLE. THE DISTAL PRONG OF THE 4984116 HANDLE THAT ALIGNS TO THE NAIL HAD BROKEN OFF. THE FRAGMENT WAS NOT RETURNED AS INDICATED IN THE COMPLAINT DESCRIPTION. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE GIVEN INFORMATION, IT IS LIKELY THAT ROUGH HANDLING AND WEAR AND TEAR CONTRIBUTED TO THE COMPLAINT CONDITIONS. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A VISUAL INSPECTION, FUNCTIONAL TEST, DEVICE HISTORY REVIEW (DHR), COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. 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 A PROCEDURE WAS BEING PERFORMED ON (B)(6) 2016 FOR A LATERAL ENTRY FEMORAL NAIL. DURING THE PROCEDURE IT WAS NOTED THAT THE INSERTION HANDLE WAS MISSING A TAB THAT PREVENTS THE NAIL FROM ROTATING. THE WHEREABOUTS OF THE MISSING TAB IS UNKNOWN. ANOTHER INSERTION HANDLE WAS BROUGHT IN; THERE WAS ALSO AN ISSUE WITH THAT HANDLE. IT APPEARS THAT THE HOLE WAS TOO SMALL, WHICH DIDN'T ALLOW FOR THE SLEEVE TO CORRECTLY FIT THROUGH. HOWEVER, THEY WERE ABLE TO USE THE INSERTION HANDLE TO FINISH THE PROCEDURE. THE SURGEON ENDED UP USING ALL AVAILABLE INSTRUMENTS AND CONTINUED TO FREEHAND THE REST OF THE PROCEDURE. THERE WAS A SIXTY (60) MINUTE SURGICAL DELAY SINCE ANOTHER INSERTION HANDLE HAD TO BE LOCATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT STATUS BEING REPORTED AS STABLE. THE REPORTER CONFIRMED THAT THERE WAS NO ALLEGATION AGAINST THE SLEEVE. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632364 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 4984114

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTIT| UNKNOWN SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANT