BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

    MDR report key: 5512949 · Received March 20, 2016

    Report

    Report Number
    0009610622-2016-00139
    Event Type
    Injury
    Date Received
    March 20, 2016
    Date of Event
    January 10, 2014
    Report Date
    February 22, 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. PRODUCT WAS DISPOSED.

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED BOTH REPORTED GUIDE WIRES TO BE THE PRODUCTS IN QUESTION. THE UNKNOWN NAIL REPORTED WAS CONSIDERED AN ASSOCIATED PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORDS INCLUDING THE PACKAGING AND STERILIZATION DOCUMENTATION OF BOTH GUIDE WIRES REVEALED NO DISCREPANCIES. THE REPORTED GUIDE WIRES WERE NOT RETURNED FOR EVALUATION BECAUSE THEY HAVE BEEN ¿DISPOSED¿ ACCORDING TO INFORMATION RECEIVED. HOWEVER, NO PRODUCT MALFUNCTION WAS REPORTED; THE ISSUE IS ABOUT AN INFECTION, ALLEGEDLY ASSOCIATED WITH TWO GUIDE WIRES, WHICH WERE PACKED IN A STERILE POUCH WITH POTENTIALLY NONCONFORMING CROSS SEAM AND THUS AFFECTED BY (B)(4). THE REPORTED GUIDE WIRES WERE CONFIRMED TO BE AFFECTED BY THE (B)(4). 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 (SEE BELOW). EXCERPTS FROM THE ¿HEALTH HAZARD EVALUATION¿ / 2015-172: (¿) ¿PRODUCT OVERVIEW: PHYSICAL PRODUCT DESCRIPTION KIRSCHNER WIRES AND GUIDE WIRES: K-WIRES AND GUIDE WIRES ARE USED IN SEVERAL NAILING SYSTEMS (GAMMA3 [1] AND T2 [2]), INTENDED TO PROVIDE GUIDANCE OF CUTTING INSTRUMENTS (E.G. AWLS, CANNULATED DRILLS AND INTRAMEDULLARY REAMERS). THESE DEVICES ARE INTENDED FOR SINGLE USE ONLY AND ARE DISTRIBUTED IN STERILE PACKAGING. (¿) DISCREPANCY: A. PFA ASSESSMENT INITIATING EVENT: BECAUSE OF DUPONT [SUPPLIER OF TYVEK POUCHES] CHANGES THEIR PRODUCTION PROCESS FOR TYVEK (POUCH L13000012 AND L13000030), STRYKER (B)(4) INITIATED A TEST TO CONFIRM THAT THE SEALING IS THE SAME AS BEFORE. DURING THE TESTS EQUIVALENCE STUDY BETWEEN OLD AND TRANSITION TYVEK MATERIAL WAS DONE ON THE 10TH OF NOVEMBER 2015. BOTH, ¿OLD¿ AND ¿NEW¿ TYVEK POUCHES HAVE FAILED THE TESTS PERFORMED BY (B)(4). DYE PENETRATION TEST REVEALED THAT THERE IS A POTENTIAL RISK THAT THE CROSS SEAM MANUFACTURED BY STRYKER PROVED TO BE OUT OF SPECIFICATION (CROSS SEAM = STERILE BARRIER SHOWS MICRO-CHANNELS WHICH ARE NOT VISUALLY IDENTIFIABLE). ROOT CAUSE INVESTIGATION FOUND THIS ISSUE TO BE CORRELATED TO A SPECIFIC WORK CENTER (B)(4). (¿) (B)(4) TRIGGERS ROOT CAUSE INVESTIGATION. CORRECTIVE ACTIONS ARE DEFINED WITHIN CAPA (B)(4). (¿) THE AFFECTED PARTS ARE ALL PACKED WITH A SINGLE STERILE BARRIER (WHICH IN THIS CASE IS THE AFFECTED ARE OF THE PACKAGING) WHICH IS A TYVEK/PE COMBINATION POUCH. THIS POUCH IS KEELED OVER ON BOTH SIDES AND PLACED INTO A PLASTIC TUBE WHICH IS CLOSED BY SILICON CAPS (GREEN). THIS OUTSIDE PACKAGING IS NOT DEDICATED AS A STERILE BARRIER AND IS NOT VALIDATED AS SUCH. (¿) HAZARD DESCRIPTION: POTENTIALLY UNSTERILE PRODUCT DUE TO MISSING SEAL INTEGRITY. RISK CONSIDERATIONS: A. FACTORS THAT MAY CONTRIBUTE TO PRODUCT RISK (I.E. PRODUCT DESIGN, MANUFACTURING PROBLEMS, OR USE ERROR). THE NONCONFORMANCE IS NOT OBVIOUS TO THE USER. FACTORS THAT MAY MITIGATE TO PRODUCT RISK (I.E DESIGN OR PROCESS FACTORS) THE SECONDARY PACKAGING IS A (PLASTIC) CLEAR TUBE WITH SILICONE CAPS AT BOTH ENDS. WHILE NOT VALIDATED AS A STERILE BARRIER, IT DOES PROVIDE ADDITIONAL PROTECTION TO THE ENCLOSED POUCH PACKAGE CONFIGURATION. FURTHERMORE, IT SHOULD ALSO BE NOTED THAT IT IS STANDARD PRACTICE FOR SURGEONS TO PRESCRIBE ANTIBIOTICS PERI-OPERATIVELY IN ORDER TO REDUCE THE RISK OF POTENTIAL INFECTION, ESPECIALLY IN SITUATIONS WHERE THE INJURY WAS CAUSED DUE TO EXCESSIVE TRAUMA. (¿) HAZARD OCCURRENCE ANALYSIS DYE PENETRATION TESTING OF THE CROSS SEAM (STERILE BARRIER) ON AVAILABLE STERILE PACKED PRODUCTS (MANUFACTURED FROM AUGUST UNTIL NOVEMBER 2015) SHOWED THAT THE STERILE BARRIER WAS NOT INTACT (MICRO CANALS THROUGH THE CROSS SEAM) ON (B)(4) OF THE TESTED SPECIMEN. THE DEFECTIVE CROSS SEAMS WERE MANUFACTURED ON A SPECIFIC WORK CENTER ((B)(4) DEVICE). THE LAST MAINTENANCE OF THE MACHINE WAS PERFORMED IN AUGUST 2015. THE MACHINE WAS RE-INSPECTED BY A SERVICE TECHNICIAN OF THE MACHINE MANUFACTURER (B)(4) ON 01.12.2015 AND REVEALED NO DEFECT ON THE MACHINE. WITH RESPECT TO MANUAL HANDLING OF THE POUCHES DURING THE SEALING PROCESS HUMAN FACTORS MAY CONTRIBUTE OCCURRENCE OF DEFECTIVE SEALING. ROOT CAUSE INVESTIGATION IS STILL ONGOING BUT REVEALED THAT THE IMPLEMENTED INSPECTION METHODS ARE UNSUITABLE TO DETECT THE IDENTIFIED MICRO CANALS WITHIN THE CROSS SEAM. (¿) (B)(4).¿ (¿) ABOVE ¿HEALTH HAZARD EVALUATION¿ / 2015-172 RESULTED FROM (B)(4), WHICH WAS FILED IN ORDER TO TRIGGER ROOT CAUSE INVESTIGATION IN CASE OF POTENTIALLY NONCONFORMING CROSS SEAMS OF TYVEK POUCHES, AND WHICH HAS LED TO CAPA (B)(4) AND TO PRODUCT FIELD ACTION (B)(4). ALL AVAILABLE INFORMATION (I.A. THE DATE OF SURGERY (WHEN THE PRODUCTS IN QUESTION WERE USED), DATE WHEN THE INFECTION OCCURRED, WHAT HAS BEEN DONE TO SOLVE THE PROBLEM) HAS BEEN REPEATEDLY 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. A REVIEW OF THE EVENT IN LINE WITH ¿DQI 13-001 HANDLING OF INFECTION COMPLAINTS¿ INCLUDING ¿DQF 13-002 INFECTION COMPLAINTS - CHECKLIST INVESTIGATOR¿ REVEALED NO CONSPICUITIES. 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. IF THE REQUIRED DATA WON¿T BE PROVIDED, A REASONABLE INVESTIGATION AND ROOT CAUSE ANALYSIS IS HARDLY POSSIBLE. HOWEVER, IN THIS CASE IT WAS REPORTED, THAT ¿PSEUDOMONAS AERUGINOSA WAS FOUND BY A CULTURE TEST.¿ THE CASE WAS PRESENTED TO A CONSULTING HCP WHO STATED: ¿PSEUDOMONAS AERUGINOSA IS A TYPICAL NOSOCOMIAL GERM (CAUSING HOSPITAL-ACQUIRED INFECTION).¿ THIS IS ALSO NOMINATED IN THE SCIENTIFIC LITERATURE: ¿PSEUDOMONAS AERUGINOSA IS AN AEROBIC, MOTILE, GRAM-NEGATIVE ROD WHICH IS RESPONSIBLE FOR 10% OF ALL HOSPITAL-ACQUIRED INFECTIONS.¿ BASED ON THE ABOVE OBSERVATIONS THE ROOT CAUSE OF THE REPORTED EVENT IS MORE LIKELY TO BE FOUND IN THE NOSOCOMIAL GERM ¿PSEUDOMONAS AERUGINOSA¿ WHICH WAS DETECTED BY A CULTURE TEST, THAN IN THE VAGUE POSSIBILITY OF INFECTION BY A GUIDE WIRE WHICH WAS PACKED IN A STERILE POUCH WITH POTENTIALLY NONCONFORMING CROSS SEAM. NEVERTHELESS, THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION GIVEN AND AN ALLEGED RELATIONSHIP BETWEEN THE INFECTION AND THE REPORTED WIRE, WHICH WAS AFFECTED BY THE (B)(4), CANNOT ENTIRELY BE EXCLUDED ACCORDING TO OUR PRESENT STATE OF KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIRST SURGERY WAS DONE ON (B)(6) 2013. AROUND (B)(6) 2013, DR. NOTICED LOOSENESS OF A SCREW. ON (B)(6) 2014 DR. CONFIRMED REDDENING AND EXPANSION OF SKIN. DR. DID DRAINAGE. PSEUDOMONAS AERUGINOSA WAS FOUND BY A CULTURE TEST. ON (B)(6) 2014, A NAIL WAS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIRST SURGERY WAS DONE ON (B)(6) 2013. AROUND (B)(6) OF 2013, DR NOTICED LOOSENESS OF A SCREW. ON (B)(6) 2014 DR CONFIRMED REDDENING AND EXPANSION OF SKIN. DR DID DRAINAGE. PSEUDOMONAS AERUGINOSA WAS FOUND BY A CULTURE TEST. ON (B)(6) 2014, A NAIL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168908 GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K024736

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention