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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 Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2016
Event Type  malfunction  
Manufacturer Narrative
Device used for treatment not diagnosis. This report is for an unknown trauma (unknown dhs)/unknown quantity/unknown lot. (other number) udi:unknown part number, udi is unavailable. The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number 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 article: yu, w. , et al (2016) proximal femoral nails anti-rotation versus dynamic hip screws for treatment of stable intertrochanteric femur fractures: an outcome analyses with a minimum 4 years of follow-up, bmc musculoskeletal disorders, 17 :1-6. Country of article: china. This was a retrospective study of 220 patients who were treated between with dynamic hip screws (dhs) or a proximal femoral nails anti-rotation (pfna) between june 2005 and november 2015 for the management of stable intertrochanteric femoral fractures (iffs). The purpose of this study was to compare outcomes and complications between dhs and pfna in the treatment of stable iffs. The primary outcome measure was re-operation rate. Follow-up was undertaken at 1, 3, 12, 15, 18, 21, 24, 36, 48 postoperative months, and at final follow-up. Radiograph outcomes were obtained at all visits. Two hundred twenty two patients (110 in the pfna group and 112 in the dhs group) were evaluated. Patients in the pfna group were implanted with a competitor's device. This complaint will only include information on the 112 patients in dhs group who were implanted with dhs: standards screw/blade system, synthes, (b)(4). Complication: dhs group. Rm: prosthetic instability (n
=
4). This report is 2 of 3 for (b)(4). This report is for unknown trauma (dhs), unknown quantity and unknown lot number.
 
Manufacturer Narrative
Device was used for treatment not diagnosis. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lnae east
west chester PA 19380
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5836383
MDR Text Key50831517
Report Number2520274-2016-13757
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,Followup
Report Date 07/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
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 Received08/16/2016
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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