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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (U.S.A.) LLC DEG TI CANN TROCH FIXATION NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES (U.S.A.) LLC DEG TI CANN TROCH FIXATION NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 456.420S
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 04/19/2019
Event Type  malfunction  
Event Description
The patient underwent right intertrochanteric femur fracture open reduction and internal fixation (orif) on [date redacted]. The patient subsequently went on to develop a right intertrochanteric nonunion. Due to increasing pain, difficulty ambulating and mobilizing, the patient was scheduled for hardware removal, total hip arthroplasty. Preoperative diagnosis: right intertrochanteric femur non-union. Post-operative diagnosis: right intertrochanteric femur non-union. Notes from the operative report: "a small stab incision was made proximally. A screwdriver was inserted in the proximal aspect of the femoral nail. The locking nuts was advanced in the bore of the nail to allow helical blade removal. Helical blade was subsequently removed over a guidewire, distal interlocking screw was also removed, broken. The remainder of the screw was tapped through the femoral canal and a small accessory incision was made anterior. Femoral nail was then removed. Gross motion stability was noted to the fracture site. All wounds were closed. The patient was then positioned in the lateral position on a regular table for total hip arthroplasty.
 
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Brand NameDEG TI CANN TROCH FIXATION NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES (U.S.A.) LLC
35 airport rd.
horseheads NY 14845
MDR Report Key8657790
MDR Text Key146633627
Report Number8657790
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number456.420S
Device Catalogue Number456420S
Device Lot Number7435409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/24/2019
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer05/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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