BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6222496 · Received January 4, 2017

    Report

    Report Number
    1719045-2017-10001
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 8, 2016
    Report Date
    December 12, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DOB & WEIGHT NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR UNKNOWN SCREW MATRIXNEURO/ACTUAL PART AND LOT NUMBER ARE UNKNOWN. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. THE SCREW TIP REMAINED IN THE BONE AND ALL FRAGMENTS WERE REMOVED BY MAKING A HOLE AROUND THE REMAINED SCREW TIP BY USING A LUER BONE RONGEURS FORCEPS AND OTHER TOOLS. 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. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: DHR REVIEW FOR THE FOLLOWING: (8) PRESUMABLE PARTS, UNKNOWN WHICH PART USED - MANUFACTURING LOCATION: (B)(4), NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THESE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING DATE: 29-JUN-2015: PART #: 04.503.104.20, LOT#: 9845183 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 04-SEP-2015: PART #: 04.503.104.20, LOT#: 9892754 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 04-SEP-2015: PART #: 04.503.104.20, LOT#: 9892754 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 17-APR-2015: PART #: 04.503.104.20, LOT#: 7982283 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 21-FEB-2016: PART #: 04.503.104.20, LOT#: H041497 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 04-SEP-2015: PART #: 04.503.104.20, LOT#: 9892709 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 03-FEB-2016: PART #: 04.503.104.20, LOT#: 9985552 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 17-FEB-2016: PART #: 04.503.104.20, LOT#: H039682 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 29-SEP-2016: PART #: 04.503.104.20, LOT#: H021450(NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. MANUFACTURING DATE: 09-MAR-2016: PART #: 04.503.104.20, LOT#: H057147 (NON-STERILE) - TI MATRIXNEURO SCREW SELF-DRILLING 4MM. 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. 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

    (B)(6). A PRODUCT INVESTIGATION WAS COMPLETED: MICROSCOPIC INVESTIGATION SHOWS BROKEN FRAGMENT OF THE SCREW. SCREW HEAD IS MISSING AND THE FRAGMENT RECEIVED DOES NOT ALLOW US TO IDENTIFY THE CORRECT PART AND DOES ALSO NOT ALLOW MEASURING OF THE RELEVANT DIMENSIONS, THEREFORE NO FURTHER EVALUATION IS POSSIBLE. WE ARE NOT ABLE TO IDENTIFY THE EXACT ROOT CAUSE FOR THE BREAKAGE OF THE SCREW. NO INDICATION FOR MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE WAS FOUND. PART OF THE DEVICE REMAINED IN THE PATIENT, DEVICE NOT CONSIDERED EXPLANTED DURING THE PROCEDURE ON (B)(6) 2016. 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CLIPPING SURGERY BY CRANIOTOMY WAS PERFORMED FOR AN UNRUPTURED CEREBRAL ANEURYSM ON (B)(6) 2016. THE PATIENT¿S CONDITION GOT WORSE DUE TO CEREBRAL HEMORRHAGE AFTER 2 DAYS, AND THE SECOND SURGERY WAS PERFORMED. DURING THE SECOND SURGERY, THE SURGEON TRIED TO REMOVE THE REPORTED SCREW, BUT THE SCREW HEAD WAS CROOKED AND BROKEN. THE SCREW TIP WAS REMAINED IN THE BONE AND ALL FRAGMENTS WERE REMOVED BY MAKING A HOLE AROUND THE REMAINED SCREW TIP BY USING A LUER BONE RONGEURS FORCEPS AND OTHER TOOLS. DUE TO THIS OCCURRENCE, THE SURGERY WAS DELAYED FOR 15 MINUTES. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT FROM THIS INCIDENT. THE PATIENT IS BEING HOSPITALIZED FOR OBSERVATION OF THE SECOND SURGERY. THE SCREW HEAD WAS COMPLETELY WORN OUT. THERE WAS NO ADVERSE CONSEQUENCE DUE TO THE INCIDENT. THERE IS NO INFORMATION AVAILABLE ABOUT SURGICAL OUTCOME. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4531 SCREW, FIXATION, BONE HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention