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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA ROD,FIXATION,INTRAMEDULLARY

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SYNTHES USA ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problems Break (1069); Difficult to Insert (1316); Failure to Align (2522)
Patient Problems Fall (1848); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Tyllianakis, a. Et all (2004). Treatment of extracapsular hip fractures with the femoral nail (pnf): long term results in 45 patients. Acta orthoaedica belgica. , 70, 444-454. Greece. This report is for an unknown proximal femoral nail system, unknown quantity, unknown lot. Other number: udi: unknown part number, udi is unavailable. (b)(4). The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Literature article received: this report is being filed after the subsequent review of the following literature article): tyllianakis, a. Et all (2004). Treatment of extracapsular hip fractures with the femoral nail (pnf): long term results in 45 patients. Acta orthoaedica belgica. , 70, 444-454. Greece. The authors retrospectively studied the results achieved with the ao/asif pfn (proximal femoral nail) system implanted to treat unstable intertrochanteric fractures of the proximal femur. 45 patients (28 women, 17 men, average age 72 years; range 29 to 93 years) were followed between june 1999 and february 2003 (mean follow up period was 20 months). Intraoperative difficulties in the insertion of the nail or screws, fracture consolidation, technical or mechanical complications and delayed union, nonunion and avascular necrosis were registered. Of 45 patients 13 experienced intra-operative complications: five (5) patients experienced difficulty with distal locking due to misalignment of the targeting device; surgeons used a free-hand technique and in two of these patients the most distal screw was not inserted. Three (3) patients experienced difficulty upon insertion of the nail which required reaming to the femoral shaft to accommodate the distal part of the nail. Three (3) patients experienced difficulty upon insertion of the nail which required an open reduction of the fracture since a closed reduction was not feasible. Two (2) patients; one with a low subtrochanteric comminuted fracture and another with a subtrochanteric segmental fracture, experienced a broken pfn nail of the more proximal distal screw after a second fall, respectively 2 and 4 months postoperatively; both were revised to a long pfn. This is report is 2 for 4 for (b)(4). This report is for an unknown proximal femoral nail system and refers to difficulty with distal locking due to misalignment of the targeting device; surgeons used a free-hand technique and in two of these patients the most distal screw was not inserted, difficulty upon insertion of the nail which required an open reduction of the fracture since a closed reduction was not feasible. Difficulty upon insertion of the nail which required an open reduction of the fracture since a closed reduction was not feasible, broken pfn nail of the more proximal distal screw after a second fall with resulted in 2 patients being revised to a long pfn.
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5841338
MDR Text Key50972450
Report Number2520274-2016-13780
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/02/2016 Patient Sequence Number: 1
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