BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

    MDR report key: 5605607 · Received April 25, 2016

    Report

    Report Number
    0009610622-2016-00224
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    March 31, 2016
    Report Date
    March 31, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 18060093S GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM LOT CODE K051925. UNKNOWN T2H NAIL IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE WAS DISPOSED.

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED BOTH REPORTED GUIDE WIRES TO BE THE PRODUCTS IN QUESTION. THE NAIL REPORTED (PRODUCT DATA UNKNOWN) IS CONSIDERED A CONCOMITANT 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 STERILE POUCHES WITH POTENTIALLY NONCONFORMING CROSS SEAMS AND THUS AFFECTED BY RA 2015-172. THE REPORTED GUIDE WIRES WERE CONFIRMED TO BE AFFECTED BY THE 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 (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: PFA ASSESSMENT INITIATING EVENT: BECAUSE OF (B)(4) [SUPPLIER OF TYVEK POUCHES] CHANGES THEIR PRODUCTION PROCESS FOR TYVEK (POUCH (B)(4)), 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 (HAWO MACHINE). (¿) (B)(4) TRIGGERS ROOT CAUSE INVESTIGATION. CORRECTIVE ACTIONS ARE DEFINED WITHIN (B)(4). (¿) DESCRIPTION OF THE PACKAGING: 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: 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) RESPECTIVELY (B)(4) OF THE TESTED SPECIMEN. THE DEFECTIVE CROSS SEAMS WERE MANUFACTURED ON A SPECIFIC WORK CENTER (HAWO 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 (HAWO) 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. (¿) BASED ON STATISTICS OF AVAILABLE TEST SPECIMEN WE HAVE TO CONCLUDE THAT (B)(4) OF THE PARTS THAT WERE PRODUCED WITH THIS PROCESS (HAWO DEVICE) HAVE TO BE REGARDED AS POTENTIALLY AFFECTED BY THE NONCONFORMANCE.¿ (¿) 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 (B)(4) AND TO PRODUCT FIELD ACTION RA 2015-172. 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 REPEATEDLY REQUESTED BY THE INVESTIGATION SITE WITHOUT RESPONSE FROM THE (B)(4). THIS ALSO APPLIES TO THE QUESTIONNAIRE ¿(B)(4) 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. A REVIEW OF THE EVENT IN LINE WITH ¿(B)(4) HANDLING OF INFECTION COMPLAINTS¿ INCLUDING ¿(B)(4) 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. 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. NEVERTHELESS, ACCORDING TO THE EVENT DESCRIPTION THE SURGEON STATED: ¿DR. DOUBT RELATION BETWEEN INFECTION AND PRODUCT RECALL (PFA2015-172).¿ ON THE BASIS OF THE LIMITED INFORMATION GIVEN, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, AN ALLEGED RELATIONSHIP BETWEEN THE INFECTION AND THE REPORTED WIRES, WHICH WERE AFFECTED BY THE RA 2015-172, CANNOT ENTIRELY BE EXCLUDED ACCORDING TO OUR PRESENT STATE OF KNOWLEDGE. 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

    IT WAS REPORTED THAT FIRST SURGERY DID ON (B)(6) 2016. (T2H) INFECTION WAS DETECTED. A NAIL WAS EXTRACTED. THE PATIENT'S BONE IS NOT FUSION YET. DR. DOUBT RELATION BETWEEN INFECTION AND PRODUCT RECALL (PFA2015-172)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIRST SURGERY DID ON (B)(6) 2016. (T2H) INFECTION WAS DETECTED. A NAIL WAS EXTRACTED. THE PATIENT'S BONE IS NOT FUSION YET. DR. DOUBT RELATION BETWEEN INFECTION AND PRODUCT RECALL (PFA2015-172).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261604 GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K04E6D0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention