BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8

    MDR report key: 5650714 · Received May 12, 2016

    Report

    Report Number
    9612488-2016-10236
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 26, 2016
    Report Date
    April 26, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE CANNULATED STARDRIVE SCREWDRIVER SHAFT (PART 03.226.004 / LOT 2213646) WAS RETURNED. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY OVER EIGHT (8) YEARS OF CONSISTENT USE; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCIES. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE SCREWDRIVER SHAFT IS AN INSTRUMENT ROUTINELY USED WITH HEADLESS COMPRESSION SCREW INSTRUMENTS AND IMPLANT SETS. THE REPORTED CONDITION WAS CONFIRMED AS A SPIRAL FRACTURE SURFACE WAS IDENTIFIED APPROXIMATELY 6MM DISTAL FROM THE LAST STEP OF THE DRIVER ENDING IN A JAGGED TIP. IT IS LIKELY THAT OVER EIGHT (8) YEARS OF CONSISTENT USE HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN NOVEMBER, 2007. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE FAIR CONDITION WITH SOME MARKINGS AND SIGNS OF WEAR ALONG ITS LENGTH. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. UPON REVIEW OF THE DEVICE HISTORY RECORDS, NO NON-CONFORMANCE REPORTS RELEVANT TO THE COMPLAINT CONDITION WERE IDENTIFIED. IT IS LIKELY THAT OVER EIGHT (8) YEARS OF CONSISTENT USE HAS LED TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL NARRATIVE: PATIENT AGE/DATE OF BIRTH, GENDER AND WEIGHT ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING LOCATION: (B)(6). MANUFACTURING DATE: NOVEMBER 20, 2007. NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NON-CONFORMANCE REPORTS 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: SEPTEMBER 15, 2006. NO NON-CONFORMANCE REPORTS 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. 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 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A SCAPHOID FRACTURE THE SCREWDRIVER TIP BROKE OFF. THE TIP OF THE SCREWDRIVER BROKE WHEN THE SURGEON HAD ANOTHER 2MM LEFT TO DRILL. THE DEVICE MALFUNCTIONED CAUSED A FIFTEEN TO THIRTY (15-30) MINUTE DELAY IN SURGERY AS ANOTHER SCREWDRIVER HAD TO BE GATHERED. THERE WERE NO FRAGMENTS LEFT WITHIN THE PATIENT. THE PATIENT'S CONDITION POST-SURGERY WAS REPORTED AS FINE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305928 CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8 SCREWDRIVERS HXX SYNTHES BETTLACH 2213646

    Patients

    Seq Age Sex Outcome Treatment
    1