BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SELZACH SCREW

    MDR report key: 6185575 · Received December 19, 2016

    Report

    Report Number
    0008031020-2016-00620
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    May 16, 2016
    Report Date
    January 20, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT A CANNULATED SELF-TAPPING COMPRESSION SCREW FIXOS Ø3.5MM WAS ALLEGED OF 'BREAKAGE DURING SURGERY' COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THESE ARE SOME OF THE POSSIBLE CAUSES: INSERTION OF THE SCREW IN DENSE CORTICAL BONE WITHOUT PRE-DRILLING. THE OPERATIVE TECHNIQUE STATES: ¿[...] THE SELF-DRILLING AND SELF-TAPPING TIP OF THE FIXOS SCREWS IS INTENDED FOR CANCELLOUS BONE. IN DENSE CORTICAL BONE, PRE-DRILLING WITH CANNULATED DRILL Ø2.7MM / Ø3.5MM (REF (B)(4)) AND USE OF THE CANNULATED TAP Ø4.0MM / 5.0MM (B)(4) IS RECOMMENDED, ESPECIALLY WHEN PLACING OBLIQUE SCREWS. [...]¿ INSERTION OF THE SCREW IN DENSE CORTICAL BONE WITH AN INAPPROPRIATE ANGLE. THE OPERATIVE TECHNIQUE CLEARLY STATES: ¿CONTACT OF FIXOS SCREW WITH DENSE BONE IN A TANGENTIAL DIRECTION MAY CAUSE A DEVIATION OF THE SCREW AND/OR A BENDING OF THE K-WIRE, WHICH MAY RESULT IN DAMAGE TO THE IMPLANT. [¿]¿ IMPLANT OF THE SCREW WITHOUT A K-WIRE. EXCESSIVE TORQUE, WHICH LEAD TO THE BREAKAGE OF THE SCREW HEAD. THE OPERATIVE TECHNIQUE SAYS: ¿[¿]GENERAL WARNING: [¿] APPLYING EXCESSIVE TORQUE DURING SCREWING MAY CAUSE DAMAGE TO THE SCREW HEAD AND SCREW DRIVER, WHICH CAN LEAD TO DIFFICULT SCREW EXTRACTION. EXTENSIVE BONE DAMAGE MAY ALSO BE A RESULT, REQUIRING ADDITIONAL SURGICAL MEASURES SUCH AS SUPPLEMENTARY SURGERY, CHANGE IN SURGICAL METHOD AND/OR REVISION SURGERY [¿]¿ THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE SCREW IS BROKEN INTO TWO DIFFERENT PIECES: THE SCREW HEAD SHOWS BROKEN BITS IN THE THREADED AREA, PROBABLY DUE TO THE USAGE OF A CLAMP AND THE BREAKAGE SURFACE SHOWS SIGNS OF TORSIONAL OVERLOAD. THE THREADED AREA OF THE SECOND PART OF THE SCREW SHOW A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO BROKEN CANNULATED STRYKER SCREWS WERE RECEIVED WITH THE PRODUCT RETURNED FOR (B)(4). THE REP COULD NOT CONFIRM THE EVENT THAT IS ASSOCIATED WITH THE BROKEN SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO BROKEN CANNULATED STRYKER SCREWS WERE RECEIVED WITH THE PRODUCT RETURNED FOR (B)(4). THE REP COULD NOT CONFIRM THE EVENT THAT IS ASSOCIATED WITH THE BROKEN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835949 UNKNOWN SELZACH SCREW IMPLANT HWC STRYKER GMBH UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other