BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENODESIS SCREW, BIOCOMPOSITE

    MDR report key: 2882096 · Received December 20, 2012

    Report

    Report Number
    1220246-2012-00261
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 4, 2012
    Report Date
    October 25, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. 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. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. 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 THERE WAS A PATIENT INFECTION. ORIGINAL PROCEDURE ON (B)(6) 2011 SLAP TEAR, BICEPS INSTABILITY AND ROTATOR CUFF TEAR OF THE LEFT SHOULDER. THERE WAS A LARGE SUPRA-ACROMIAL SPUR. PRP (PLATELET RICH PLASMA) WAS INJECTED INTO THE REPAIR SITE. INCISION WAS WELL HEALED. ON (B)(6) 2011 PATIENT WAS SEEN BY SURGEON FOR A SWOLLEN SITE. A CULTURES WAS TAKEN AND SHOWED PROPIONIBACTERIUM ACNES. ON (B)(6) 2011 REVISION WITH REMOVAL OF SCREW, AR-1580BC. PER SURGEON, INFECTION APPEARS TO BE LOCALIZED TO INSERTION SITE OF THE AR-1580BC EVEN THOUGH ANOTHER IMPLANT (AR-1927BCFT) WAS ALSO IMPLANTED. PATIENT DOING WELL. WILL BE MONITORED FOR FURTHER SIGNS OF INFECTION. A BONE SCAN HAS BEEN DISCUSSED BUT NOT DONE AT THIS POINT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENODESIS SCREW, BIOCOMPOSITE SCREW, FIXATION, BONE HWC ARTHREX, INC. 360891

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other AR-1927BCFT- SUTURE ANCHOR, BIO-COMP. LOT 434508