BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTREMITY IMPLANT

    MDR report key: 6943536 · Received October 12, 2017

    Report

    Report Number
    1818910-2017-26388
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 12, 2017
    Report Date
    September 12, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    MJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE RETURNED DEVICES WERE REVIEWED BY R & D (SHOULDERS) AND A REPORT WAS RECEIVED STATING; FOR THE ANALYSIS OF (B)(4), THE SUPERIOR- LATERAL CUTTING GUIDE WAS CORRECTLY ASSEMBLED WITH THE CUTTING PLATE AND THEN AFFIXED TO A CUTTING HANDLE EXACTLY AS ILLUSTRATED IN THE DELTA XTEND TECHNIQUE GUIDE. ALL FIVE SIZES OF THE CUTTING HANDLE WERE INSPECTED, WITH ONLY THE 10MM CODE SHOWN IN THE PHOTOS BELOW. USING A SIMULATED ANATOMICAL MODEL, THE ORIENTATION PIN WAS PASSED THROUGH THE HOLE IN THE CUTTING HANDLE AT THE DESIRED RETROVERSION. THIS PIN IS ALIGNED IN THE DIRECTION OF THE FOREARM, AS EXPECTED . THERE WAS NO ISSUE WITH THE CORRECTLY ASSEMBLED INSTRUMENTATION. THE ISSUE SEEN IN THE OPERATING ROOM MAY HAVE BEEN CAUSED BY INCORRECT ASSEMBLY OF THE SUPERIOR -LATERAL CUTTING GUIDE OR NOT CORRECTLY SEATING THE CUTTING HANDLE ON THE CUTTING GUIDE. IF THIS WERE TO BE INCORRECTLY ASSEMBLED, THE DESIRED RETROVERSION WOULD NOT BE POSSIBLE, AS STATED IN THE ORIGINAL COMPLAINT. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. POST MARKET SURVEILLANCE IS PER SEP 419. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP IS BEING SUBMITTED TO FILL THE GAP IN FOLLOW-UP SEQUENCE NUMBERS.

    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. H10 ADDITIONAL NARRATIVE: THE COMPLAINT DESCRIPTION STATES THAT THE ROTATION INDICATED BY THE VERSION ROD DID NOT MATCH THE HUMERAL HEAD ANATOMY AND THE PLACEMENT OF THE CUTTING GUIDE WITH THE KIT IN QUESTION WAS INDICATING AN INCORRECT CUT. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 · 0

    COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE ROTATION INDICATED BY THE VERSION ROD DID NOT MATCH THE HUMERAL HEAD ANATOMY AND THE PLACEMENT OF THE CUTTING GUIDE WITH THE KIT IN QUESTION WAS INDICATING AN INCORRECT CUT. WHEN THE ALTERNATIVE KIT WAS OPENED AND USED ON THE SAME PATIENT IN THE SAME WAY, THE CUT WAS POSITIONED CORRECTLY WITH REGARDS TO THE PATIENTS ANATOMY. THERE IS NO OBVIOUS DEFECT WITH THE KIT HOWEVER THE HOSPITAL HAVE REQUESTED THAT THIS KIT IS SWAPPED OUT. / / INVESTIGATION METHOD: PRODUCT ANALYSIS NO PRODUCT RETURNED DHR REVIEW: NOT PERFORMED AS NO LOT N° WAS PROVIDED. NO OTHER ANALYSIS WAS POSSIBLE BECAUSE THE PRODUCT CODES AND BATCH NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. / INVESTIGATION SUMMARY: THE COMPLAINT DESCRIPTION STATES THAT THE ROTATION INDICATED BY THE VERSION ROD DID NOT MATCH THE HUMERAL HEAD ANATOMY AND THE PLACEMENT OF THE CUTTING GUIDE WITH THE KIT IN QUESTION WAS INDICATING AN INCORRECT CUT. THE DEVICES ASSOCIATED TO THE COMPLAINT WERE NOT RETURNED FOR ANALYSIS. NO OTHER ANALYSIS WAS POSSIBLE BECAUSE THE PRODUCT CODES AND BATCH NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    COMPLETE PRODUCT DETAIL HAS NOT BEEN RECEIVED AT THIS TIME. IF FURTHER INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 THE ROTATION INDICATED BY THE VERSION ROD DID NOT MATCH THE HUMERAL HEAD ANATOMY AND THE PLACEMENT OF THE CUTTING GUIDE WITH THE KIT IN QUESTION WAS INDICATING AN INCORRECT CUT. WHEN THE ALTERNATIVE KIT WAS OPENED AND USED ON THE SAME PATIENT IN THE SAME WAY, THE CUT WAS POSITIONED CORRECTLY WITH REGARDS TO THE PATIENTS ANATOMY. THERE IS NO OBVIOUS DEFECT WITH THE KIT HOWEVER THE HOSPITAL HAVE REQUESTED THAT THIS KIT IS SWAPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726355 UNKNOWN EXTREMITY IMPLANT SHOULDER INSTRUMENT/TRIAL MJT DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown