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

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.

• Type of Device: ROD,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 Key: 5841338
• MDR Text Key: 50972450
• Report Number: 2520274-2016-13780
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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 Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention