BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIOCOMP SUTURETAK SMALL JOINT

    MDR report key: 2771311 · Received October 4, 2012

    Report

    Report Number
    1220246-2012-00190
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    November 9, 2011
    Report Date
    September 6, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. 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. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(64) 2011, PATIENT HAD THE ORIGINAL ACHILLES REPAIR AND A BONE SPUR SURGERY. ON (B)(6) 2012, PATIENT DEVELOPED A SEVERE INFECTION. THE SURGEON OPENED THE INCISION AND PERFORMED SOME CLEANING OF THE AREA. PATIENT CONTINUED WITH PAIN AND STILL CONTINUED WITH THE INFECTION. SURGEON REQUESTED FOR PATIENT TO GET A SECOND MRI, AND NOTICED ON ONE OF THE FOUR SCREWS IMPLANTED, AN INFECTION HAD DEVELOPED. THE SCREW HAD NOT DISSOLVED LIKE THE OTHER THREE. SURGEON RETRIEVED THE FOURTH SCREW FROM PATIENT (BIO-TENODESIS). AREA WAS DEBRIDED ,EXCESS BONE REMOVED DOWN TO GOOD BLEEDING BONE AND INSERTED A NEW IMPLANT (AR-8934BCNF) WITH ANTIBIOTICS, PT, WAS IN A 3 SIDED SPLINT. ON (B)(6) 2012, PATIENT RETURNED TO DR. WITH INFECTION OF THE RIGHT ACHILLES TENDON. ANTIBIOTICS WERE GIVEN AND, BONE WAS FOUND NOT TO BE EXCESSIVELY SOFT. THE INFECTED AREA WAS DEBRIDED ALONG WITH PART OF CALCANEUS AND THOROUGHLY IRRIGATED. BLOOD FLOW GOOD TO POSTERIOR HEEL. PT. WAS PUT INTO A BOOT WITH HEEL LIFT FOR IMMOBILIZATION TEMPORARILY. FURTHER ANTIBIOTIC COVERAGE IS BASED ON HIS CULTURE RESULTS. NO REPORT HAS BEEN PROVIDED FOR TYPE OF INFECTION. PT HAS INCURRED EXTENSIVE PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE ANCHOR, BIOCOMP SUTURETAK SMALL JOINT FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 415843

    Patients

    Seq Age Sex Outcome Treatment
    1 Other