BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM

    MDR report key: 7919985 · Received September 28, 2018

    Report

    Report Number
    8030965-2018-56827
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    September 4, 2018
    Report Date
    September 4, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. NO PRODUCT WAS RETURNED; THE INVESTIGATION WAS PERFORMED BASED ON THE RECEIVED IMAGE. UPON REVIEW OF THE IMAGE, IT CAN BE CONFIRMED THAT THE NAIL AND HELICAL BLADE ARE PARTIALLY ASSEMBLED. THE CAUSE FOR THE DEVICE INTERACTION ISSUE IS NOT ABLE TO BE DETERMINED. REVIEW OF THE RISK DOCUMENTATION DETERMINED THAT THE COMPLAINT CONDITION IS ADEQUATELY ADDRESSED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AFTER THE MANUFACTURING INVESTIGATION OF THE RECEIVED IMAGE, THE INITIALLY REPORTED CONCOMITANT DEVICE HELIACAL BLADE IS DETERMINED AS THE REPORTABLE DEVICE. 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

    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. MANUFACTURING DATE: JUNE 02, 2016; PART: 456.318; 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM; LOT: H038387 (NON-STERILE); LOT QUANTITY: 6 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA WITH NO RELEVANT ISSUES. INSPECTION SHEET, IN-PROCESS/INSPECT DIMENSIONAL/FINAL, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: PART: 456.314.3; LOCK DRIVER TFN, BP55; LOT: H082285; LOT QUANTITY: 202 . WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INSPECT DIMENSIONAL / FINAL MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 456.315.2; LOCK PRONG TFN, BP58; LOT: 9926348; LOT QUANTITY: 63 . WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN PROCESS ACCEPTANCE MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 21069; TIALNBRI18.00, BP80; LOT: 9838522; LOT QUANTITY: 4,489 LBS. PRODUCT CERTIFICATION RECEIVED FROM DYNAMET WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. NO PRODUCT WAS RETURNED; THE INVESTIGATION WAS PERFORMED BASED ON THE RECEIVED IMAGE. UPON REVIEW OF THE IMAGE, IT CAN BE CONFIRMED THAT THE NAIL AND HELICAL BLADE ARE PARTIALLY ASSEMBLED. THE CAUSE FOR THE DEVICE INTERACTION ISSUE IS NOT ABLE TO BE DETERMINED. REVIEW OF THE RISK DOCUMENTATION DETERMINED THAT THE COMPLAINT CONDITION IS ADEQUATELY ADDRESSED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 0

    UPON REVIEW OF THE IMAGE, IT CAN BE CONFIRMED THAT THE NAIL AND HELICAL BLADE ARE PARTIALLY ASSEMBLED. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL DEVICE PRODUCT CODE: HWC. GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER ¿S PHONE NUMBER NOT PROVIDED FOR REPORTING. (B)(4) USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED: THE NAIL AND LOCKING SCREW COULD NOT BE DISASSEMBLED AFTER THE LOCKING SCREW BROKE. THE PATIENT SUSTAINED A FRACTURE WHILE THE SURGEON WAS REMOVING THE NAIL AND SCREW. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NUMBER: 456.318, 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM, LOT NUMBER: H038387 (NON-STERILE): LOT QUANTITY: 6 MANUFACTURING DATE: 02-JUN-2016: NR WAS GENERATED AT FINAL INSPECTION. THE NR WAS FOR A DOCUMENTATION ERROR. INSPECTION SHEET WAS INCOMPLETE WITH A MISSED ENTRY. THE LOT WAS DISPOSITIONED AS ¿REWORK¿ AND ALL 6 PIECES PASSED THE REWORK INSPECTION. THIS DOCUMENTATION NR WOULD NOT BE RELEVANT TO THE REPORTED COMPLAINT CONDITION OF COMPONENT BREAKAGE. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ISSUE DETAILED ABOVE. INSPECTION SHEET, IN-PROCESS/INSPECT DIMENSIONAL/FINAL, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD/LPF REV AB WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: PART NUMBER: 456.314.3, LOCK DRIVER TFN, BP55, LOT NUMBER: H082285, LOT QUANTITY: 202. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INSPECT DIMENSIONAL / FINAL, 456FI314-3 REV H MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 456.315.2, LOCK PRONG TFN, BP58, LOT NUMBER: 9926348, LOT QUANTITY: 63. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN PROCESS ACCEPTANCE, OP067580 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET NS043861 REV G MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21069, TIALNBRI18.00, BP80, LOT NUMBER: 9838522, LOT QUANTITY: 4,489 LBS. PRODUCT CERTIFICATION RECEIVED FROM DYNAMET DATED 29-MAY-2015 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 17-JUN-2015 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING A HIP SURGERY, A TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL WAS BLOCKED BEFORE REACHING THE DESIRED POINT WHILE INSERTED INTO THE MEDULLARY CAVITY. IT DID NOT ADVANCE OR MOVE BACK BECAUSE A PART OF THE LOCKING SCREW BROKE, CAUSING AN OBSTRUCTION IN THE HOLE AND A COLD FUSION. IT WAS IMPOSSIBLE TO REMOVE IT PIECE BY PIECE, WHICH FRACTURED THE LATERAL CORTEX OF THE RIGHT FEMUR AND THE PATIENT ALSO SUFFERED DIAPHYSEAL FRACTURE. THE ATTEMPT WAS MADE TO PLACE A LONGER NAIL BUT THE SUBSTRATE IS VERY POOR AND THERE WAS NO WHERE TO FIX THE NAIL AT THE PROXIMAL LEVEL. THE PATIENT HAD A FRACTURE MUCH LARGER THAN THE POSSIBILITY OF REDUCING. AND FINALLY, WITHOUT HAVING MORE OSTEOSYNTHESIS MATERIAL AT HAND, THE PATIENT WAS LEFT WITH SKELETAL TRACTION FOR A FUTURE INTERVENTION. CONCOMITANT DEVICE REPORTED: 11MM TITANIUM HELICAL BLADE 85MM (PART #: 456.302, LOT #: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TROCH FIXATION NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759073 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH H038387

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention