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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - SCREWS: PFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Break (1069)
Patient Problems Non-union Bone Fracture (2369); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Pma/510k: this report is for an unknown pfna screws/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: yanbin, l. Et al (2014), treatment of long-segment fracture at middle-up part of femur with long proximal femoral nail antirotation, the journal of the pakistan medical association, vol. 64 (12 suppl. 2), pages s64-69 (china). The aim of this retrospective study is to investigate the results of non-invasive operation method and evaluate clinical and radiological outcome of long proximal femoral nail antirotation in treating long-segment fracture at middle-up part of femur. Between june 2006 to december 2013, a total of 139 patients (104 male and 35 female), with a mean age of 48. 8 (range 18-86) years, were included in the study. Surgery was performed using pfna-long. Follow-ups were performed at 1, 2, 3, 6, 9 and 12 months postoperatively, and at least once a year thereafter. The mean follow-up period was unknown. The following complications were reported as follows: 1 patient had poor harris hip functional score. 2 patients developed coxa vara, crispation, and significant displacement of trochanter, pain in medial hip, increasing limb crispation, and partially limited range of motion (rom). 4 cases of screw breakage with phase i non-union, shortening and angular deformity also got healed after the second operation, however, the patients had amyotrophy and limited motion of hip and knee joints. This report is for an unknown synthes pfna screws. It captures the reported screw breakage with phase i non-union, shortening and angular deformity and underwent second operation; amyotrophy and limited motion of hip and knee joints. This is report 1 of 2 for (b)(4).
 
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Brand NameUNK - SCREWS: 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 Key12345077
MDR Text Key267439584
Report Number8030965-2021-06926
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 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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