BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 6944357 · Received October 12, 2017

    Report

    Report Number
    2520274-2017-12449
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. NUMBER 510K: THIS REPORT IS FOR TWO (2) UNKNOWN 2.0MM CORTEX SCREWS, PARTIAL PART NUMBER 401.8XX. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. EXPLANT WAS SCHEDULED FOR (B)(6) 2017. IT HAS NOT BEEN VERIFIED THAT THIS PROCEDURE TOOK PLACE OR WAS SUCCESSFUL. DATE OF EXPLANT IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT SCREWDRIVER BLADES, PART 314.670, LOTS 9200088 AND LOT 8701631, WERE RETURNED AND HAVE BEEN FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. HOSPITAL TELEPHONE NOT AVAILABLE FOR REPORTING. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). 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

    CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED X-RAYS. X-RAY REVIEW DID NOT SHOW ANY BROKEN SCREWS. THE COMPLAINED ISSUE (DURING THE REMOVAL SURGERY, AFTER THE SURGEON REMOVED 5 SCREWS, THE SURGEON WAS NOT ABLE TO REMOVE 2 SCREWS. THE HEAD OF THE SCREW MIGHT HAVE BEEN STRIPPED. AS A RESULT TWO SCREWS AND THE PLATE WERE LEFT IN THE PATIENT) COULD NOT BE CONFIRMED. UNFORTUNATELY NO SCREWS AND NO PLATE WERE RETURNED FOR INVESTIGATION. CONCOMITANT DEVICES RETURNED: 1X 314.670 / 8701631 / SCREWDRIVER SHAFT 1.5/2.0, CRUCIFORM. DHR-REVIEW: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 11/27/2013. NO NCRS 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. VISUAL INSPECTION DID SHOW SLIGHT MARKS OF USE. AS THIS SCREW IS RATED AS CONCOMITANT, NO VISUAL DAMAGE COULD BE FOUND WE DO PROVIDE VISUAL, FUNCTIONAL AND DHR-REVIEW /CHECK. NO MEASUREMENTS, NO HARDENING AND NO OTHER TESTS WERE PROVIDED. 1X 314.670 / 9200088 / SCREWDRIVER SHAFT 1.5/2.0, CRUCIFORM. DHR-REVIEW: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 10/20/2014. NO NCRS 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. VISUAL INSPECTION DID SHOW SLIGHT MARKS OF USE. AS THIS SCREW IS RATED AS CONCOMITANT, NO VISUAL DAMAGE COULD BE FOUND WE DO PROVIDE VISUAL, FUNCTIONAL AND DHR-REVIEW /CHECK. THE TWO CONCOMITANT ARTICLES WERE FORWARDED TO PLANT (B)(4) FOR FUNCTIONAL CHECK: THE FUNCTION WAS TESTED AND FOUND TO BE OKAY. EXACT ROOT CAUSE FOR THIS COMPLAINED ISSUE COULD NOT BE DETERMINED. OVER ALL CONCLUSIONS: BASED ON THE PROVIDED VISUAL INSPECTION, FUNCTIONAL CHECK AND DHR-REVIEW NO MANUFACTURING RELATED DEVIATION COULD BE FOUND. UNFORTUNATELY THE COMPLAINED SCREWS WERE NOT RETURNED AND COMPLAINED ISSUE COULD NOT BE CONFIRMED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 2.0MM T-PLATE AND SCREWS FOR A FIRST METACARPAL FRACTURE ON (B)(6) 2013. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR HARDWARE REMOVAL AS PART OF THE TREATMENT PLAN. DURING THE REMOVAL PROCEDURE, SURGEON WAS ABLE TO REMOVE FIVE (5) OF THE SCREWS, BUT COULD NOT REMOVE THE REMAINING TWO (2) SCREWS. IT WAS NOTED THE HEAD OF THE SCREWS MAY HAVE BEEN STRIPPED. AS A RESULT, TWO (2) 2.0MM CORTEX SCREWS AND THE PLATE REMAINED IMPLANTED. ANOTHER REMOVAL SURGERY WAS PLANNED FOR (B)(6) 2017. CONCOMITANT DEVICES REPORTED: 2.0MM T-PLATE 3-HOLES HEAD/8 HOLES SHAFT (447.233S, LOT 7871116, QUANTITY 1), 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, SHORT (314.670, LOT 8701631, QUANTITY 1), 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, SHORT (314.670, LOT 9200088, QUANTITY 1). THIS REPORT IS FOR TWO (2) UNKNOWN CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725280 SCREW,FIXATION,BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention