BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM HEX FLEXIBLE SCREWDRIVER

    MDR report key: 5883347 · Received August 17, 2016

    Report

    Report Number
    2520274-2016-14166
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 2, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE COMPLAINT WAS ABLE TO BE CONFIRMED AT CUSTOMER QUALITY. ONE (1) 5MM HEX FLEXIBLE SCREWDRIVER (PART 03.037.028, LOT 9298608, MFG. 24-FEB-2015) WAS RETURNED WITH A COMPLAINT STATING THAT THE SCREWDRIVER HAD DIFFICULTY ENGAGING THE SET SCREW AND THEN APPEARED DEFORMED AT A JOINT WHEN REMOVED. THE SCREWDRIVER LATER BROKE INTO TWO PIECES ON THE BACK TABLE. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED. THE COMPLAINT WAS ABLE TO BE CONFIRMED AT CUSTOMER QUALITY. THE SCREWDRIVER WAS RETURNED BROKEN AT THE FIRST DISTAL FLEXIBLE SEGMENT. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE PART# 03.037.010 LOT# 9762055 AND PART# 03.037.011 LOT# 9910363 WERE RECEIVED UNOPENED WITHOUT A COMPLAINT CONDITION ALLEGED OR IDENTIFIED DURING THE INVESTIGATION. THE SALES REPRESENTATIVE CONFIRMED THAT THESE WERE UN-NEEDED REPLACEMENT PARTS. THE TWO ITEMS WILL BE FORWARDED TO CREDIT AND RETURNS. THE SCREWDRIVER WAS RETURNED BROKEN AT THE FIRST DISTAL FLEXIBLE SEGMENT. THE BALANCE OF THE DEVICE SHOWS SOME WEAR AND TEAR. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE; HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY OVER-TORQUEING OF THE DEVICE. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS OF PART 03.037.028 LOT 9298608 HAS BEEN REQUESTED. 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. 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 HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 24. FEB. 2015, PART# 03.037.028 LOT# 9298608 . 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. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. 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

    IT WAS REPORTED THAT A SCREWDRIVER WAS DIFFICULT TO ENGAGE WITH AND HARD TO REMOVE FROM A SET SCREW DURING A PROCEDURE TO REPAIR A LEFT HIP FRACTURE ON (B)(6) 2016. AS THE 5MM HEXAGONAL FLEXIBLE SCREWDRIVER WAS USED TO TIGHTEN THE SET SCREW DOWN IN THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA), THERE WAS DIFFICULTY ENGAGING THE SET SCREW. SUBSEQUENTLY, THERE WAS DIFFICULTY REMOVING THE SCREWDRIVER FROM THE SCREW, REQUIRING FORCE. WHEN IT WAS REMOVED, THE DRIVER APPEARED DEFORMED AT ONE OF THE JOINTS. AFTER IT WAS TAKEN TO THE BACK TABLE, THE SCREWDRIVER BROKE INTO TWO PIECES. ANOTHER INSTRUMENT WAS AVAILABLE FOR USE. THERE WAS NO REPORTED SURGICAL DELAY AND NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES TWO DEVICES CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART #04.038.290, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535356 5MM HEX FLEXIBLE SCREWDRIVER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 9298608

    Patients

    Seq Age Sex Outcome Treatment
    1