BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI RIB HOOK CAP/EXTENDED

    MDR report key: 2558555 · Received April 18, 2012

    Report

    Report Number
    2530088-2012-00221
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    April 6, 2012
    Report Date
    March 21, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE RIB HOOK WAS RECEIVED IN GOOD CONDITION, WITH NO SIGNS OF MISUSE. THE RIB HOOK MAY HAVE WORN THROUGH THE BONE DUE TO PATIENT ACTIVITY OR PERHAPS POOR BONE QUALITY. THIS COULD NOT BE DETERMINED FROM THE RETURNED DEVICE ALONE. THE FRACTURED IMPLANT MAY BE DUE TO EXCESSIVE STRAIN AND OR OTHER PATIENT ACTIVITY. THIS CANNOT BE DETERMINED FROM THE RETURNED DEVICE ALONE. THE RISK ANALYSIS WAS REVIEWED AND WAS FOUND TO BE ADEQUATE FOR THE CONSTRUCT MIGRATING.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION. VISUAL INSPECTION SHOWED SLIGHT ANODIZE REMOVAL ON THE CORNERS, WHICH IS CONSISTENT WITH USE. BASED ON THE DHR REVIEW, VISUAL EVALUATION, AND MEASUREMENT ANALYSIS, THE COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY FOR THE (B)(4) TI RIB HOOK CAP/EXTENDED, LOT 6816824, SHOWED THAT THERE ARE NO ISSUES DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT. REVIEW OF RAW MATERIAL P/N (B)(4), LOT 4935858, SHOWS THAT THERE ARE NO ISSUES THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS REC'D.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    THERE WAS NO CLEAR EVENT DATE. THEREFORE, IT WAS REMOVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT RECEIVED (B)(4) 2012 AND MISPLACED. PRODUCT WAS FOUND (B)(4) 2013. DEVICE HAS BEEN SENT FOR ADDITIONAL EVALUATION.

    Description of Event or Problem · 1

    THIS RECORD IS 1 OF 3 FOR COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2011, A (B)(6) FEMALE WAS IMPLANTED WITH A VEPTR 90 DEGREE LEFT S-HOOK. DURING A ROUTINE CONSTRUCT ADJUSTMENT ON (B)(6) 2012, IT WAS FOUND THAT THE IMPLANT HAD CRACKED AT THE PARALLEL CONNECTOR. ON (B)(6) 2012, PT WAS REVISED AND ALL HARDWARE WAS REMOVED. DURING THE REVISION, IT WAS NOTED THAT A RIB CAP HAD WORN THROUGH THE BONE. PT WAS THEN IMPLANTED WITH ANOTHER OF THE SAME CONSTRUCT. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI RIB HOOK CAP/EXTENDED TI RIB HOOK CAP MDI SYNTHES BRANDYWINE 6816824

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention S-HOOK| RIB HOOK| PARALLEL CONNECTOR