BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-WIRE, RECON T2 RECON Ø3.2X400 MM

    MDR report key: 5970491 · Received September 22, 2016

    Report

    Report Number
    0009610622-2016-00441
    Event Type
    Injury
    Date Received
    September 22, 2016
    Date of Event
    October 9, 2011
    Report Date
    December 29, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THE K-WIRE TO BE THE PRODUCT IN QUESTION. NO FURTHER ASSOCIATED PRODUCT WAS REPORTED. THE REPORTED K-WIRE WAS NOT RETURNED FOR EVALUATION BECAUSE IT HAS BEEN ¿DISPOSED¿ ACCORDING TO INFORMATION RECEIVED. HOWEVER, NO PRODUCT MALFUNCTION WAS REPORTED; THE ISSUE IS ABOUT AN INFECTION, WHEREAS ACCORDING TO THE EVENT DESCRIPTION THE SURGEON DOUBTS IN A CORRELATION BETWEEN THE INFECTION AND THE RECALL ISSUE BECAUSE THE PATIENT HAD A COMPOUND FRACTURE. THE REPORTED K-WIRE WAS PACKED IN A STERILE POUCH WITH POTENTIALLY NONCONFORMING CROSS SEAM AND THUS AFFECTED BY PRODUCT FIELD ACTION RA 2015-172. SUBJECT OF THE ABOVE MENTIONED RECALL ACTION WAS THE STERILE PACKAGING OF MISCELLANEOUS BATCHES OF GUIDE WIRE(S), K-WIRE(S) AND INTRAMEDULLARY METAIZEAU PINS; A DYE PENETRATION TEST REVEALED THAT THERE IS A POTENTIAL RISK THAT THE CROSS SEAM MANUFACTURED BY STRYKER PROVED TO BE OUT OF SPECIFICATION. (B)(4) WAS FILED IN ORDER TO TRIGGER ROOT CAUSE INVESTIGATION IN CASE OF POTENTIALLY NONCONFORMING CROSS SEAMS OF TYVEK POUCHES AND HAS LED TO (B)(4) AND TO PRODUCT FIELD ACTION RA 2015-172 ((B)(4)). THE EVENT WAS REVIEWED IN LINE WITH ¿DQI 13-001 HANDLING OF INFECTION COMPLAINTS¿; FOR FURTHER DETAILS REFER TO ¿DQF 13-002 INFECTION COMPLAINTS - CHECKLIST INVESTIGATOR¿ ATTACHED IN TRACKWISE. ALL AVAILABLE INFORMATION (I.A. THE DATE OF SURGERY (WHEN THE PRODUCT IN QUESTION WAS USED), DATE WHEN THE INFECTION OCCURRED, WHAT HAS BEEN DONE TO SOLVE THE PROBLEM) HAS BEEN REQUESTED BY THE INVESTIGATION SITE WITHOUT RESPONSE FROM THE (B)(4). THIS ALSO APPLIES TO THE QUESTIONNAIRE ¿DQF 13-003 INFECTION COMPLAINTS - CHECKLIST CUSTOMER¿, WHICH WAS SENT OUT AS MANDATORY IN INFECTION CASES; THE (FILLED OUT) FORM WAS NOT RETURNED, NO REPLY FROM THE (B)(4) WAS RECEIVED. LIKEWISE, NO FURTHER INFORMATION REGARDING THE KIND OF INFECTION (E.G. MICROBIOLOGICAL GERM-PROOF WITH RESISTOGRAM) WAS PROVIDED. IN THOSE CASES WHERE THE REPORTED INFECTION IS ALLEGEDLY ASSOCIATED WITH A WIRE AFFECTED BY THE RECALL RA 2015-172, A COMPREHENSIVE INVESTIGATION IS TO BE CARRIED OUT, WHICH REQUIRES MUTUAL INTEREST IN CO-OPERATING IN COLLECTING AND EXCHANGE OF NECESSARY INFORMATION AND DATA OF BOTH COMPLAINANT AND MANUFACTURER. WE HAVE RECEIVED NO INFORMATION REGARDING OTHER POTENTIAL SOURCES OF INFECTION, INCLUDING BUT NOT LIMITED TO THE PATIENT OR THE FACILITY. IF THE REQUIRED DATA WON¿T BE PROVIDED, A REASONABLE INVESTIGATION AND ROOT CAUSE ANALYSIS IS NOT POSSIBLE AND ANY STATEMENT WOULD FURTHERMORE ONLY BE BASED ON ASSUMPTIONS. HOWEVER, IN THIS CASE IT WAS REPORTED THAT ¿DR. THOUGHT INFECTION DIDN'T RELATE TO RECALL ISSUE BECAUSE A PATIENT HAD A COMPOUND FRACTURE.¿ NEVERTHELESS, ON THE BASIS OF THE LIMITED INFORMATION GIVEN THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE FILE WILL BE CLOSED FORMALLY IN ACCORDANCE TO OUR STANDARD PROCEDURES. IF SUBSTANTIVE INFORMATION FOR AN EFFECTIVE ROOT CAUSE DETERMINATION WILL BECOME AVAILABLE THE CASE WILL BE RE-OPENED AND REVIEWED.

    Description of Event or Problem · 1

    THIS IS RELATED TO RECALL (B)(4). FIRST SURGERY WAS (B)(6) 2011. PATIENT HAD INFECTION. DR. THOUGHT INFECTION DIDN'T RELATE TO RECALL ISSUE BECAUSE A PATIENT HAD A COMPOUND FRACTURE.

    Description of Event or Problem · 1

    THIS IS RELATED TO RECALL RA2015-172. FIRST SURGERY WAS (B)(6) 2011. PATIENT HAD INFECTION. DR. THOUGHT INFECTION DIDN'T RELATE TO RECALL ISSUE BECAUSE A PATIENT HAD A COMPOUND FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622016 K-WIRE, RECON T2 RECON Ø3.2X400 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K281822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other