BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, PEEK SWIVELOCK C

    MDR report key: 2882024 · Received December 20, 2012

    Report

    Report Number
    1220246-2012-00257
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT; NO ISSUES WERE FOUND WITH THE STERILIZATION OF THIS LOT. THIS DEVICE IS SUPPLIED STERILE. RESULTS OF CULTURE TAKEN/TYPE OF ORGANISM(S) IDENTIFIED WERE REQUESTED BUT NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE POST-OPERATIVE INFECTION COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE FOR THIS TYPE OF EVENT IS A NOSOCOMIAL SOURCE OR PATIENT NON-COMPLIANCE WITH POST-OP WOUND CARE DIRECTIONS. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. FACILITY WILL NOT RETURN THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PATIENT INFECTION, ORIGINAL SURGERY (B)(6) 2012. RIGHT SHOULDER ARTHROSCOPY WITH DEBRIDEMENT OF SLAP TEAR, ARTHROSCOPIC SUBACROMIAL DECOMPRESSION, ARTHROSCOPIC DISTAL CLAVICLE EXCISION, REMOVAL OF MULTIPLE OSSEOUS LOOSE BODIES, AND MINI-OPEN ROTATOR CUFF REPAIR. PATIENT HAD FEVER ON (B)(6) 2012 AND ADMITTED TO HOSPITAL. ON (B)(6), EXTENSIVE DEBRIDEMENT OF THE SUBACROMIAL SPACE AND GLENOHUMERAL JOINT. THE ROTATOR CUFF REPAIR APPEARED INTACT. PICC LINE WAS PLACED AND PATIENT SENT HOME ON (B)(6) 2012 ON VANCOMYCIN. ON (B)(6) 2012, PATIENT RE-ADMITTED. DIAGNOSIS- ABSCESS. ORGANISM IS PROPIONIBACTERIUM ACNES. FURTHER SURGERY SUGGESTED TO REMOVE IMPLANTS, HOWEVER PATIENT AND FAMILY WANT TO WAIT. PATIENT FEELS PAIN IS DECREASING. CONTINUES TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE ANCHOR, PEEK SWIVELOCK C FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 569351

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other