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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA SHORT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH UNK - CONSTRUCTS: PFNA SHORT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Migration (4003)
Patient Problem Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown pfna short construct/unknown lot. Part and lot number are unknown; udi number is unknown. Date of implantation is an unknown date between (b)(6) 2010 and (b)(6) 2012. Complainant part is not expected to be returned for manufacturer review/investigation. Fax number: (b)(6). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. 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 review of the following journal article: helin, m. Et al. (2015), does the pfna nail limit impaction in unstable intertrochanteric femoral fracture? a 115 case-control series, orthopaedics & traumatology: surgery & research, vol 101, pages 45-49 (france). The objectives of this study were: to validate the ender classification to assess fracture stability; to determine whether neck shortening, and head purchase quality varied with stability; and to determine the functional impact of femoral neck shortening. Between september 2010 and september 2012, patients underwent fracture fixation used the titanium pfna nail (synthes, etu-pes, france). The patients were divided into 2; 45 patients under unstable fractures and 70 patients under stable fractures. The following complications were reported: 8 patients died. An (b)(6) year-old female patient had an early disassembly with fracture impaction and blade cut-out from the femoral head. 1 patient had simple lavage for surgery site infection. 2 patients had disassembly for mechanical reasons (cut-out or cut-through) requiring revision by total hip replacement within 3 months. This report is for an unknown synthes pfna. This is report 1 of 3 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PFNA SHORT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12341930
MDR Text Key267251539
Report Number8030965-2021-06832
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
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: 08/19/2021 Patient Sequence Number: 1
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