BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR Ø1.5 SELF-DRILL L6 TAN 4U I/CLIP

    MDR report key: 6382745 · Received March 6, 2017

    Report

    Report Number
    3000270450-2017-10078
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 9, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (BRAND NAME SCR Ø1.5 SELF-DRILL L6 TAN 4U I/CLIP, PART NUMBER 04.503.226.04S). TWO LOT NUMBERS, L123230 AND L166918, WERE REPORTED FOR THE SUBJECT DEVICE BUT IT IS UNKNOWN WHICH LOT NUMBER IS ASSOCIATED WITH THE RETURNED SUBJECT DEVICE. THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING THE SCREW BROKE INTRAOPERATIVELY DURING INSERTION. THE SCREW WAS RETURNED DAMAGED. THE THREADS ARE DAMAGED ON THE SHAFT AND ONLY A PORTION OF THE HEAD REMAINS. THE ENTIRE SCREW HEAD WAS NOT RECEIVED. SCREW WAS MADE OUT OF (B)(4). THE MATERIAL WAS CHECKED AND FOUND TO BE ACCEPTABLE. THE SCREW HEAD IS BROKEN AND THE THREADS ON THE SHAFT ARE DAMAGED. NO FEATURES RELEVANT TO THE COMPLAINT CONDITION COULD BE CHECKED DUE TO THE SCREW DAMAGE ON THE HEAD AND THE SHAFT. THE AVAILABLE DATA SUPPORTS THE COMPLAINANT¿S DESCRIPTION THAT THE SCREW IS BROKEN, THEREFORE THIS COMPLAINT IS CONFIRMED. HOWEVER, SINCE ALL THE RELEVANT FEATURES COULD NOT BE EVALUATED IT IS UNKNOWN IF THE CAUSE OF THE COMPLAINT CONDITION IS A RESULT OF THE MANUFACTURING PROCESS. A ROOT CAUSE COULD NOT BE IDENTIFIED. AS PREVIOUSLY REPORTED, DEVICE HISTORY RECORD REVIEWS OF BOTH REPORTED LOTS REVEALED THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE LOTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. ADDITIONAL NARRATIVE: THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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. ADDITIONAL NARRATIVE: THE LOT NUMBER OF THE REPORTED SCREW IS EITHER L123230 OR L166918. IT IS UNKNOWN WHICH LOT NUMBER IS ASSOCIATED WITH THE SCREW THAT BROKE. (B)(4). EXPIRATION DATE UNKNOWN. LOT NUMBER UNKNOWN. (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. (B)(6). THE 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE BOTH THE REPORTED LOTS THAT MAY BE ASSOCIATED WITH THE SUBJECT DEVICE. MANUFACTURING LOCATION: SYNTHES (B)(4). LOT NUMBER L123230: DATE OF MANUFACTURE: SEP 7, 2016. EXPIRATION DATE: AUG 1, 2026. LOT NUMBER L166918. DATE OF MANUFACTURE: OCT 18, 2016. EXPIRATION DATE: OCT 1, 2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT LOTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ONE (1) SCREW BROKE DURING MAXILLARY PLASTIC SURGERY ON (B)(6) 2017. WHEN THE SURGEON TRIED TO INSERT THE SCREW INTO THE MAXILLA, ONE (1) OF THE FOUR (4) SCREWS BROKE. THE SURGERY DELAYED FOR SEVERAL MINUTES (DURATION UNKNOWN), BUT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT BODY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED; NO OTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162692 SCR Ø1.5 SELF-DRILL L6 TAN 4U I/CLIP SCREW, FIXATION, BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1