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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA GMBH GAMMA LONG NAIL R1.5 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA GMBH GAMMA LONG NAIL R1.5 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3525-0440S
Device Problems Break (1069); Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544)
Event Date 06/05/2020
Event Type  malfunction  
Event Description
Notes from h&p: injury list. Left intertrochanteric femur fracture. Procedures: s/p left intertrochanteric femur fracture intramedullary rod fixation history of present illness (hpi): status post fall on the left hip. The patient was walking when he felt a sudden increase in pain in his left hip. The next day he was unable to ambulate very well. Assessment: s/p left intertrochanteric femur fracture s/p open reduction internal fixation (orif) and hardware failure. Notes from the operative report: preoperative diagnoses:. Left intertrochanteric femur fracture. Left femur, failure of hardware. Postoperative diagnoses: left intertrochanteric femur fracture. Left femur, failure of hardware. Type of operation: left femur revision, open reduction and internal fixation. Left femur, removal of hardware. Indications for surgery: middle-aged male status post left intertrochanteric femur, intramedullary (im) rodding initially performed by an orthopedic surgeon. The patient subsequently went on to have a hardware failure with _____ fracture of his implants at hardware. "using the patient's old surgical incision sites, several stab incisions were made for removal of the old broken intramedullary nail. After the old gamma nail was subsequently removed with a nail hook and rongeur and screwdriver, a ball-tipped guidewire was placed down the intramedullary canal and then the femur was re-reamed up into a size 15 reamer. The proximal aspect of the femur was reamed to a 16. A 13cm nail was then placed down the intramedullary canal. A guidewire was placed into the femoral head and neck for a lag screw fixation. As dual integrated screws were placed, achieving compression across the fracture and near anatomic alignment. A total of 2 distal interlocking screws were placed using perfect circle technique and intraoperative fluoroscopic imaging. Final fluoroscopic images were taken and saved and showed an anatomically reduced left intertrochanteric femur fracture. " md's description of the incident: gamma 3 nail that broke thru proximal screw aperture at 6 weeks. Nail was noted to be notched most likely at time if insertion. Nail was initially implanted on [date redacted]. It was found to be broken in x-ray ~1. 5 months later.
 
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Brand NameGAMMA LONG NAIL R1.5
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA GMBH
325 corporate drive
mahwah NJ 07430
MDR Report Key10378266
MDR Text Key202055245
Report Number10378266
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 08/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3525-0440S
Device Catalogue Number3525-0440S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/05/2020
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer08/07/2020
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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