BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX15MM

    MDR report key: 2490546 · Received March 14, 2012

    Report

    Report Number
    1818910-2012-05826
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 23, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NDJ
    PMA / PMN Number
    MM 33-28
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: THIS REPORT IS STILL CONSIDERED CLOSED. 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

    **UPDATE** 2/23/2012 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THE PATIENT WAS REVISED TO ADDRESS PAIN AND SQUEAKING. THE CUP AND SCREWS WERE ADDED TO THE COMPLAINT. (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    QTY - 2 BONE SCREWS. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION. BASED ON THE INABILITY TO FIND ANY ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. PER NR-(B)(4) A MEDICAL RECORD REVIEW IS NOT REQUIRED FOR THIS COMPLAINT RECORD. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-(B)(4) APPENDIX A. - WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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 · 1

    PATIENT CONTACTED DEPUY REQUESTING COMPENSATION. HE CLAIMS HE EXPERIENCED INTERMITTENT SQUEAKING AND CATCHING. **UPDATE** (B)(6) 2012 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THE PATIENT WAS REVISED TO ADDRESS PAIN AND SQUEAKING.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX15MM BONE SCREWS NDJ DEPUY ORTHOPAEDICS INC US 430918

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention