BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM

    MDR report key: 7700047 · Received July 18, 2018

    Report

    Report Number
    8030965-2018-55148
    Event Type
    Injury
    Date Received
    July 18, 2018
    Report Date
    June 27, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819739666
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RECEIVED. PART: 456.325; LOT: 6962308; MANUFACTURING QTY:(B)(4); MANUFACTURING DATE: JUNE 12, 2012; MANUFACTURING LOCATION: (B)(4); RM LOT: 6881247. PRODUCT WAS INSPECTED AND PASSED. THERE WERE NO NONCONFORMANCE (NCS) OR REWORKS GENERATED DURING THE MANUFACTURE OF THIS LOT. RAW MATERIAL RECEIVED FROM PERRYMAN COMPANY. CERTIFICATIONS RECEIVED FROM PERRYMAN COMPANY INDICATE MATERIAL WAS PROCESSED TO REQUIRED SPECIFICATIONS. THERE WERE NO NCS OR REWORKS GENERATED DURING THE MANUFACTURE OF THIS MATERIAL. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) (DHR) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION FLOW: BROKEN VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF POSTOPERATIVE BREAKAGE, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. THE NAIL BROKE AT AN OBLIQUE ANGLE AND THE BREAK PATTERN IS ALSO JAGGED. THE BREAK IS LOCATED AT THE DISTAL LOCKING HOLE. THE MAJORITY OF THE DEVICE SHOWS WEAR CONSISTENT WITH IMPLANTATION AND REMOVAL. DOCUMENT/SPECIFICATION REVIEW: THE RETURNED DEVICE WAS MANUFACTURED IN JUNE 2012. PRODUCT WAS INSPECTED AND PASSED. THERE WERE NO NCS OR REWORKS GENERATED DURING THE MANUFACTURE OF THIS LOT. RAW MATERIAL RECEIVED FROM PERRYMAN COMPANY. CERTIFICATIONS RECEIVED FROM PERRYMAN COMPANY INDICATE MATERIAL WAS PROCESSED TO REQUIRED SPECIFICATIONS. THERE WERE NO NCS OR REWORKS GENERATED DURING THE MANUFACTURE OF THIS MATERIAL. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. TABULATED PRODUCT DESIGN DRAWING FOR THE FAMILY OF CANNULATED TROCHANTERIC FIXATION NAILS (TFN) WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. RISK DOCUMENTATION: FOR ALL TFN NAILS; COMPLAINT CONDITION: BROKEN-POST OP THE COMPLAINT HISTORY WAS REVIEWED FROM JANUARY 2008 THROUGH AUGUST 2018. THE TFN NAIL FAMILY IMPLANTS AND INSTRUMENTS DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. DIMENSIONAL INSPECTION: THE OUTSIDE DIAMETER OF THE RETURNED NAIL AT LOCATION OF BREAKAGE MEASURED Ø10.03MM AT CQ (CALIPERS CA592) WHICH IS WITHIN SPECIFICATION OF Ø10.00MM +0.05/-0.15MM PER DESIGN DRAWING. THE INSIDE DIAMETER/CANNULATION OF THE RETURNED NAIL AT LOCATION OF BREAKAGE MEASURED Ø4.50MM AT CQ (GAUGE PIN GP29) WHICH IS WITHIN SPECIFICATION OF Ø4.60MM +/-0.1MM PER DESIGN DRAWING. MATERIAL ANALYSIS: RAW MATERIAL RECEIVED FROM PERRYMAN COMPANY. CERTIFICATIONS RECEIVED FROM PERRYMAN COMPANY INDICATE MATERIAL WAS PROCESSED TO REQUIRED SPECIFICATIONS. THERE WERE NO NCS OR REWORKS GENERATED DURING THE MANUFACTURE OF THIS MATERIAL. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE NAIL BREAKING POSTOPERATIVELY COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION AND THE COMPLAINT CONDITION IS ADEQUATELY ADDRESSED BY THE RISK ASSESSMENT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN DEVICE BROKE. ADDITIONAL PROCODE: HWC. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. FACILITY NAME AND REPORTER CONTACT INFORMATION IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. CODE (B)(4) USED TO CAPTURE REQUIRED SURGICAL INTERVENTION AND DEVICE REMOVAL. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT IMPLANT REMOVAL DUE TO STEM BREAKAGE OF A TROCHANTERIC FIXATION NAIL (TFN). THE PATIENT WAS IMPLANTED WITH THE TFN NAIL, HELICAL BLADE, AND LOCKING SCREW ON (B)(6) 2012. IT WAS UNKNOWN IF THERE WAS FURTHER MEDICAL INTERVENTION REQUIRED OR IF THERE WAS A SURGICAL DELAY DURING THE REVISION. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES: 11.0MM TITANIUM HELICAL BLADE 95MM (PART: 456.304, LOT: UNKNOWN, QUANTITY: 1), 4.9MM TITANIUM LOCKING BOLT 32MM (PART: 459.320, LOT: UNKNOWN, QUANTITY: 1) . THIS REPORT IS FOR A 10MM / 130G TI CANN TROCH FIXATION NAIL 235MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542749 10MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 6962308 07611819739666

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THERAPY DATE: (B)(6) 2012