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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA LONG ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - CONSTRUCTS: PFNA LONG ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
There are multiple patients all information is provided in the article. This report is for an unknown pfna long construct/unknown lot. Part and lot number are unknown; udi number is unknown. Implant date is between (b)(6) 2015. Complainant part is not expected to be returned for manufacturer review/investigation. 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: chmielnicki m. , prokop a. , (2015) pertrochanteric femur fracture - our technique and results, z orthop unfall volume 153, pages 137-140 (germany) doi http://dx. Doi. Org/10. 1055/s-1383196. This study aims to demonstrate the operation technique by video and our own results of the last two years. From january 1 to december 31 , 2015 , 210 patients with an average age of 80. 7 years with pertrochanteric femur fractures were treated with pfna from synthes. Women were affected in 77% of the cases. The following complications were reported as follows: - four patients died of cardiovascular failure with asa 3 and 4 during the inpatient stay. - hospital mortality in all patients from 2007 to 2011 who underwent surgery for proximal femur fractures in our hospital. 1057 patients underwent surgery. 722 patients were operated on within the first 24 hours, 209 patients after more than 24-48 hours, and 126 patients > 48 hours after admission. Hospital mortality for surgery on day 1 was 4. 1%, 7. 2% by day 2, and 8% after 48 hours. -only in the 16 patients operated over 2 hours, 1 death occurred due to intraoperative cardiovascular failure in a 92-year-old female patient. - 1 infection. - 6 hematomas and seromas that were surgically drained. - 6 misplaced implants. - 6 blade migration and cutouts. This report is for an unknown synthes pfna. A copy of the literature article is being submitted with this medwatch. This report is for one (1) unknown pfna long construct. This is report 1 of 13 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PFNA LONG
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key12287916
MDR Text Key265390889
Report Number8030965-2021-06459
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received07/09/2021
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: 08/06/2021 Patient Sequence Number: 1
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