BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE

    MDR report key: 6416938 · Received March 20, 2017

    Report

    Report Number
    1719045-2017-10242
    Event Type
    Injury
    Date Received
    March 20, 2017
    Report Date
    February 23, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (12MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE, PART NUMBER 04.037.214S, LOT NUMBER H041939). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: IT WAS REPORTED A TROCHANTERIC FIXATION NAIL ¿ ADVANCED (TFNA) (PART 04.037.214S, LOT H041939, MFG 24-FEB-2016) FAILED AT THE BLADE/NAIL JUNCTION POSTOPERATIVELY ((B)(4)). IT WAS ALSO REPORTED THAT THE SURGEON HAD DIFFICULTY REMOVING THE NAIL WITH THE EXTRACTION INSTRUMENTS ((B)(4)). THE IMPLANTS WERE RECEIVED AFTER BOTH EVENTS HAD OCCURRED THEREFORE THE AS RECEIVED DAMAGE CANNOT BE DISASSOCIATED FROM EITHER COMPLAINT. THE RETURNED IMPLANTS WERE EVALUATED AT CUSTOMER QUALITY AND THE COMPLAINT CONDITION OF POSTOPERATIVE BREAKAGE WAS ABLE TO BE CONFIRMED HOWEVER THE COMPLAINT CONDITION OF WILL NOT FIT WITH OTHER PARTS WAS NOT ABLE TO BE REPLICATED OR CONFIRMED. THE MATING EXTRACTION INSTRUMENTS WERE NOT RETURNED THEREFORE A FUNCTIONAL TEST COULD NOT BE PERFORMED. ADDITIONALLY, USE OF THE 03.037.030 EXTRACTOR FOR BLADE/SCREW FOR REMOVAL OF THE NAIL WAS DETERMINED TO BE MISUSE/ABUSE AS THE INSTRUMENT IS ONLY INDICATED FOR EXTRACTION OF THE HELICAL BLADE OR LAG SCREW. THE TFNA TECHNIQUE GUIDE DSEM/TRM/0514/0052(9) 03/17) RECOMMENDS USING THE 355.399 EXTRACTION HOOK FOR TI CANNULATED NAILS FOR REMOVAL OF BROKEN NAILS. RELEVANT PRODUCT DRAWINGS WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENTS¿ LOT NUMBERS AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, RISK ASSESSMENT REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE FOLLOWING PART(S) WERE RETURNED AS A CONCOMITANT DEVICES WITHOUT AN ALLEGED COMPLAINT CONDITION: --TFNA AUGMENTED HELICAL BLADE ¿ 04.038.385, LOT 7866730, --5.0MM TI LOCKING SCREW W/ T25 STARDRIVE RECESS ¿ 04.005.520, LOT 9584701 (PER COMPLAINT DESCRIPTION). UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION. THE AS RECEIVED DAMAGE ON BOTH DEVICES IS CONSISTENT WITH IMPLANTATION AND REMOVAL. THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THE DEVICE(S). ALL MEASUREMENTS WERE PERFORMED WITH MITUTOYO CALIPERS. BROKEN NAIL: THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE GIVEN DETAILS HOWEVER IT IS LIKELY THAT THE PATIENT'S ADVANCED AGE AS WELL AS PATIENT NON-COMPLIANCE COULD HAVE CONTRIBUTED TO THE FAILURE OF THE NAIL 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

    PATIENT IDENTIFIER, DATE OF BIRTH AND WEIGHT IS NOT AVAILABLE FOR REPORTING. PATIENT¿S AGE IS REPORTED AS ELDERLY. (B)(4). (THERAPY DATE): SIX MONTHS AGO, EXACT DATE IS UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART #: 04.037.214S, LOT#: H041939 (STERILE) - 12 MM/125 DEG TI CANN TFNA 235 MM/TIGHT- STERILE. QUANTITY 3: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24-FEB-2016, EXPIRATION DATE: 31-JAN-2025. INSPECTION SHEET FOR IN PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET - TFNA ASSEMBLY INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.912.2 - LOCK PRONG 125 DEGREE, TFNA BP-55 LOT ¿ 9668029, 04.037.912.4 - WAVE SPRING, SHIM ENDED BP-55 LOT ¿ 7921061, 04.037.912.3 - TFNA LOCK DRIVE BP-58 LOT ¿ 9969523, 21127 - RAW MATERIAL LOT BP-80 LOT ¿ 7926421. NO NON CONFORMANCE REPORTS (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. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SIX MONTHS AGO THE SURGEON OPERATED ON A ELDERLY PATIENT TO TREAT A SUBTROCHANTERIC FRACTURE. A TFNA (TROCHANTERIC FEMORAL NAIL-ADVANCED) FEMORAL NAIL Ø 12 MM, RIGHT, 125°, L 235 MM WAS USED WITH CABLE TO REDUCE AND STABILIZE FRACTURE. POSTOPERATIVELY ON AN UNKNOWN DATE THE TFNA NAIL FAILED AT THE APERTURE, DROPPING PROXIMAL FRAGMENT INTO VARUS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 AND A NEW NAIL (14 MM LONG 140 DEGREE) WAS INSERTED. THE FRACTURE WAS GRAFTED. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: 1.7 MM COCR CABLE WITH TI CRIMP 750 MM-STERILE (PART # 611.105.01S, QUANTITY 1), TFNA FENESTRATED HELICAL BLADE 85 MM - STERILE (PART# 04.038.385S, LOT # 7866730, QUANTITY 1). THIS REPORT ADDRESSES THE POST-OPERATIVE EVENT OF BROKEN NAIL. THE INTRAOPERATIVE ISSUES DURING EXTRACTION OF THE NAIL HAVE BEEN CAPTURED UNDER LINKED (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL CONCOMITANT PART: LOCKING SCREW (PART 04.005.520, LOT 9584701, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201362 12MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT H041939

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BLADE (PART# 04.038.385S, LOT # 7866730, QTY 1)| CABLE (PART # 611.105.01S, LOT # UNKNOWN, QTY 1)