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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 Date 02/06/2016
Event Type  Injury  
Manufacturer Narrative

Device was used for treatment not diagnosis. Additional narrative: this report is for unknown pins/unknown quantity/unknown lot. Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

This report is being filed after the subsequent review of the following journal article: kazemian, g, et al. (2016) external fixation vs. Skeletal traction for treatment of intertrochanteric fractures in the elderly. (b)(4). The aim of this study is to compare two different treatment modes for intertrochanteric fractures in elderly patients. Between (b)(6) 2011 and (b)(6) 2012, sixty elderly patients; 21 men and 39 women with an age range of 61 to 98 years with intertrochanteric fractures were randomized for treatment with either skeletal traction (group a) or an external fixation secured with four pins (synthes, (b)(4)) (group b). During the 12-month follow-up period in group b in one patient, the reduction was lost because of cutout and varus collapse, as indicated by comparisons with the radiographs taken immediately after surgery. This report is for unknown pins/unknown quantity/unknown lot. This is report 2 of 2 for (b)(4).

 
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Type of DevicePIN,FIXATION,SMOOTH
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key6060293
Report Number2520274-2016-15090
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2016
Is This An Adverse Event Report? Yes
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 Received10/19/2016
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

Patient TREATMENT DATA
Date Received: 10/27/2016 Patient Sequence Number: 1
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