BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4812137 · Received June 2, 2015

    Report

    Report Number
    2520274-2015-14180
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION CONFIRMED THAT AN AFFILIATE FACILITY IN (B)(4) RECEIVED THE DEVICE ON JUNE 5, 2015. AS OF YET, THE COMPLAINANT PART HAS NOT BEEN RETURNED TO THE MANUFACTURING INVESTIGATION SITE FOR REVIEW. 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

    POTENTIAL PART AND LOT NUMBERS WERE PROVIDED; IT IS UNKNOWN WHICH WERE THE COMPLAINED SCREWS: PART 402.212S WITH LOT NUMBER 7899996: BRAND NAME: 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-12MM, PRODUCT CODE: HRS AND HWC, MANUFACTURER: (B)(4), EXPIRATION DATE: 01MAY2022, 510K NUMBER: K113364, MANUFACTURING DATE: 15MAY2012, PART 402.872S WITH LOT NUMBER 7792379: BRAND NAME: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM, PRODUCT CODE: HWC, MANUFACTURER: (B)(4), EXPIRATION DATE: 01FEB2022, 510K NUMBER: K112583, MANUFACTURING DATE: 28FEB2012. PART 402.874S WITH LOT NUMBER 7792380: BRAND NAME: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM, PRODUCT CODE: HWC, MANUFACTURER: (B)(4), EXPIRATION DATE: 01FEB2022, 510K NUMBER: K112583, MANUFACTURING DATE: 27FEB2012. PART 402.876S WITH LOT NUMBER 7952223: BRAND NAME: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM, PRODUCT CODE: HWC, MANUFACTURER: (B)(4), EXPIRATION DATE: 01JUNE2022, 510K NUMBER: K112583, MANUFACTURING DATE: 20JUNE2012. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR ALL POTENTIALLY INVOLVED LOT NUMBERS: THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE PARTS WERE REVIEWED WITH THE FOLLOWING RESULT: 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. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. EVENT DATE: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS. PART AND LOT NUMBERS WERE NOT PROVIDED BY REPORTER. EXPLANT DATE IS UNKNOWN. UNSPECIFIED INTERVENTION TO TREAT SECONDARY ROTATION DISLOCATION OF THE LIMB. 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. THE SUBJECT DEVICES HAVE REPORTEDLY BEEN DISCARDED. 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

    AN INTERNAL REVIEW OF THE RECEIVED X-RAYS WAS COMPLETED BY A DEPUY SYNTHES MEDICAL DIRECTOR WITH RESULTS AS FOLLOWS: "MOVEMENT CERTAINLY APPEARS TO HAVE OCCURRED AT THE OSTEOTOMY SITE AS DESCRIBED."

    Description of Event or Problem · 1

    IT WAS REPORTED FIVE SCREWS WERE IMPLANTED. THE PATIENT UNDERWENT SHOCK WAVE THERAPY, WHICH HAS ENDED. AFTER THE NEXT X-RAY RESULTS, HOW TO PROCEED WILL BE DECIDE.THIS REPORT IS FOR FIVE UNKNOWN SCREWS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 20 DAYS AFTER A 6-HOLE PLATE WAS IMPLANTED IN THE PATIENT DURING AN ULNAR OSTEOTOMY PROCEDURE, A SECONDARY ROTATION DISLOCATION OF THE LIMB OCCURRED. SECONDARY INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357036 SCREW, FIXATION, BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention