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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA PIN, FIXATION, SMOOTH

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SYNTHES USA PIN, FIXATION, SMOOTH Back to Search Results
Device Problem Migration or Expulsion of Device
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Chaudhary, d (2012). The proximal femoral nail ¿ a minimal invasive treatment for the stabilization of pertrochanteric and subtrochanteric femoral fractures. Jk science, vol. 14, no. 3, pp. 120-124. India. This report is for unknown pin/unknown quantity/unknown lot. 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. (b)(4).

 
Event Description

This report is being filed after the subsequent review of the following literature article: chaudhary, d (2012). The proximal femoral nail - a minimal invasive treatment for the stabilization of pertrochanteric and subtrochanteric femoral fractures. Jk science, vol. 14, no. 3, pp. 120-124. India. This randomized prospective study was conducted to determine the suitability of proximal femoral nail (pfn) as an appropriate method for minimal invasive treatment of pertrochanteric & subtrochanteric femoral fractures. Participants included 17 males and 8 females, with a mean age of 56. 3 years. Post-surgery follow ups were at 2 weeks interval for the first 3 months, and then 4 weeks interval til the fracture union or fixation failure. The salvati and wilson hip scoring system, kyles criteria, and radiographic analysis were used at follow up assessment. At 6 months follow up, the ambulatory status was assessed to include the need for assistance devices and pain felt on weight bearing. The following complications were reported: in one patient, the antirotation hip pin cut through because it was longer than the neck screws which did not allow the sliding of the screws through the nail during weight bearing. This is report 2 of 4 for (b)(4). This report is for an unknown pin.

 
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Type of DevicePIN, FIXATION, SMOOTH
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 Key5803707
Report Number2520274-2016-13515
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/07/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/07/2016
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

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