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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: PFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown pfna constructs/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. 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. Zhao, k. Et al. (2020), treatment of unstable intertrochanteric fractures with proximal femoral nailing antirotation: traction table or double reverse traction repositor, journal of investigative surgery, vol. Xx, pages 1-7 (china). The objective of this retrospective study was to compare the efficacy of the double reverse traction repositor (drtr) and traction table with proximal femoral nailing antirotation (pfna) in the treatment of unstable intertrochanteric fractures. From january 2017 to june 2017, a total of 66 patients with unstable intertrichanteric fractures were treated with a pfna. They were divided into 2 groups. 30 patients had the drtr. There were 6 males and 24 females. 36 patients had the traction table. There were 15 males and 21 females. Follow-up was performed at 1, 3, 6, and 12 months, including radiographic evaluations for fracture healing and postoperative complications. The following complications were reported as follows. 2 patients had died in follow-up. 24 patients had deep vein thrombosis. 5 patients had superficial wound infections. This report is for an unknown synthes pfna constructs. It captures the reported deep vein thrombosis and superficial wound infections. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11426915
MDR Text Key248799906
Report Number8030965-2021-01687
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2021
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 Received02/11/2021
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: 03/07/2021 Patient Sequence Number: 1
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