BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIO- SUTURETAK, SMALL JOINT

    MDR report key: 3770604 · Received April 24, 2014

    Report

    Report Number
    1220246-2014-00062
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K050749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF ADVERSE EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. ALLERGIC-LIKE REACTIONS TO PLA MATERIALS (PLLA, PLDLA) HAVE BEEN REPORTED. THESE REACTIONS HAVE SOMETIMES NECESSITATED THE REMOVAL OF THE IMPLANT. PRODUCT DIRECTIONS FOR USE WARNS OF POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. 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 ON (B)(6) 2013, THE PATIENT HAD AN ARTHROSCOPIC BROSTROM W/INTERNAL BRACE LIGAMENT REPAIR. FROM HER FIRST POST-OP APPOINTMENT AT TWO WEEKS, THE PATIENT HAD UNDEFINED PROBLEMS (REPORTER DID NOT KNOW WHAT THEY WERE). PATIENT HAD A FOLLOW-UP, INCLUDING 2 SURGERIES TO WASHOUT WOUND AND ATTEMPT CLOSURE. ABOUT 8 MONTHS POST-OP, THE PATIENT NEVER HEALED AND ALSO HAD RECURRENT INSTABILITY. IN (B)(6) 2014, THE PATIENT FINALLY WENT BACK TO THE O.R. REVISION WAS PERFORMED BY ANOTHER SURGEON IN A DIFFERENT CITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250193 SUTURE ANCHOR, BIO- SUTURETAK, SMALL JOINT SCREW, FIXATION, BONE HWC ARTHREX, INC. 615283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-2325PSLC, PEEK SWIVELOCK, LOT 522181| AR-2324PSLC, PEEK SWIVELOCK, LOT 603795.