BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI STERNAL LOCKING DOUBLE-T PLATE/14 HOLES

    MDR report key: 8119330 · Received November 30, 2018

    Report

    Report Number
    2939274-2018-55178
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Report Date
    November 12, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10887587055176
    PMA / PMN Number
    K093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: DEVICE EVALUATED BY MFR, DEVICE MANUFACTURE DATE: DEVICE HISTORY. PART MFG DATE: 05-NOV-2015, PART EXP. DATE: N/A, MANUFACTURING LOCATION: DEPUY SYNTHES ¿ ELMIRA, LOT NUMBER: 9941215, PART NUMBER: 460.038. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR FINAL PRODUCT 460.038 REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS LOT#: 9941215 OF TI STERNAL LOCKING DOUBLE-T PLATE/14 HOLES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE ASSEMBLY THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW: THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE EVALUATED BY MFR: INVESTIGATION SUMMARY: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE EMERGENCY RELEASE PIN IN A STERNAL LOCKING DOUBLE T-PLATE WAS BROKEN IN PLATE. THE BROKEN PIN COULD NOT BE REMOVED FROM THE PLATE HOLE TO REPLACE WITH NEW PIN. THERE WAS NO PATIENT INVOLVEMENT. FLOW: BROKEN, VISUAL INSPECTION: VISUAL INSPECTION SHOWS THAT THE EMERGENCY RELEASE PIN (PART NUMBER: 460.022) HAS AN OBLIQUE FRACTURE AND A PORTION OF BOTH DISTAL TIPS ARE MISSING FROM THE DEVICE. ONE DISTAL TIP IS INSIDE ONE OF THE HOLES THAT HOLDS BOTH PIECES TOGETHER OF THE TI STERNAL LOCKING T PLATE, THE OTHER DISTAL TIP WAS NOT RETURNED. THE BALANCE OF THE DEVICE IS IN FAIR CONDITION. THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION FOR BROKEN AND IS CONFIRMED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED TO BE USE ERROR, MISUSE/ABUSE, NONCOMPLIANCE, POSTOPERATIVE TRAUMA. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. A DEVICE HISTORY REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER, AND NO NCRS, NO MRRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. MATERIAL/HARDNESS REVIEW: THE MATERIAL WAS REVIEWED, AND NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. INVESTIGATION CONCLUSION: BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE COMPLAINT ARE UNKNOWN. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HWC, JDQ A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS DISCOVERED THAT THE EMERGENCY RELEASE PIN ON THE STERNAL LOCKING DOUBLE T-PLATE WAS BROKEN. THE PIN COULD NOT BE REMOVED FOR REPLACEMENT. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) STERNAL LOCKING DOUBLE T-PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959852 TI STERNAL LOCKING DOUBLE-T PLATE/14 HOLES PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 460.038 9941215 10887587055176

    Patients

    Seq Age Sex Outcome Treatment
    1