BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4815081 · Received June 3, 2015

    Report

    Report Number
    2520274-2015-14221
    Event Type
    Injury
    Date Received
    June 3, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    ADDITIONAL NARRATIVE: PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN. EVENT DATE: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS/UNKNOWN LOTS. IT WAS NOT REPORTED IF THE DEVICE WAS EXPLANTED DURING THE REVISION PROCEDURE. 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. 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

    POTENTIAL PART AND LOT NUMBERS WERE PROVIDED; IT IS UNKNOWN WHICH WERE THE COMPLAINED SCREWS: PART 402.214S LOT NUMBER 7936435: BRAND NAME: 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-14MM, PRODUCT CODES: HRS AND HWC, MANUFACTURER: (B)(4), EXPIRATION DATE: 01MAY2022, 510K NUMBER: K113364, MANUFACTURE DATE: 08JUNE2012. PART 402.872S LOT NUMBER 7792379: BRAND NAME: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM, PRODUCT CODE: HWC, MANUFACTURE: (B)(4), EXPIRATION DATE: 01FEB2022, 510K NUMBER: K112583, MANUFACTURE DATE: 28FEB2012. PART 402.874S LOT NUMBER 9209766: BRAND NAME: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM, PRODUCT CODE: HWC, MANUFACTURE: (B)(4), EXPIRATION DATE: 01OCT2024, 510K NUMBER: K112583, MANUFACTURE DATE: 21OCT2014. PART 402.874S WITH LOT NUMBER 9292108: BRAND NAME: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM, PRODUCT CODE: HWC, MANUFACTURE: (B)(4), EXPIRATION DATE: 01DEC2024, 510K NUMBER: K112583, MANUFACTURE DATE: 16DEC2014. PART 402.876S WITH LOT NUMBER 9203602: BRAND NAME: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM, PRODUCT CODE: HWC, MANUFACTURE: (B)(4), EXPIRATION DATE: 01OCT2024, 510K NUMBER: K112583, MANUFACTURE DATE: 17OCT2014. PART 402.876S WITH LOT NUMBER 7952223: BRAND NAME: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM, PRODUCT CODES: HWC, MANUFACTURE: (B)(4), EXPIRATION DATE: 01JUNE2022, 510K NUMBER: K112583, MANUFACTURE 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 NCRS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING THE OSTEOTOMY OF ULNA THE SURGEON USED A SIX-HOLE PLATE ACCORDING TO THE TECHNIQUE GUIDES. AFTER TWENTY (20) DAYS IT WAS NOTICED A SECONDARY ROTATION DISLOCATION OF THE LIMB. THIS REQUIRED A REVISION SURGERY. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: AN INTERNAL REVIEW OF THE RECEIVED X-RAYS HAS BEEN COMPLETED BY A DEPUY SYNTHES MEDICAL DIRECTOR WITH RESULTS AS FOLLOWS: I HAVE REVIEWED THE X-RAYS AND THE COMPLAINT HISTORY AND CAN CONFIRM THAT THERE SEEMS TO BE OPENING OF THE OSTEOTOMY SITE AND ROTATION OF THE LIMB AS DESCRIBED IN THE COMPLAINT DESCRIPTION. THERE IS NO EVIDENCE OF SCREW BACK OUT OR BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT EXPLANT HAS NOT YET OCCURRED. AFTER THE NEXT X-RAY RESULTS, HOW TO PROCEED WILL BE DECIDE. PROBABLY AN EXPLANT, A BONE GRAFT AND A NEW PLATE IMPLANT WILL BE NEEDED. THIS REPORT IS FOR SIX UNKNOWN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357249 SCREW, FIXATION, BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention