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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: TFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: TFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK - CONSTRUCTS: TFN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Literature citation: goodnough, l. H. Et al. (2022), risk of revision after hip fracture fixation using depuy synthes trochanteric fixation nail or trochanteric fixation nail advanced, the journal of bone and joint surgery, vol. 00, pages 1-8 (usa). The investigation could not be completed; no conclusion could be drawn, as no product was received. 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: goodnough, l. H. Et al. (2022), risk of revision after hip fracture fixation using depuy synthes trochanteric fixation nail or trochanteric fixation nail advanced, the journal of bone and joint surgery, vol. 00, pages 1-8 (usa). The primary purpose of this study was to evaluate the risk of revision related to the index fracture following hip fracture repair using the tfna compared with the tfn in a large u. S. Integrated health-care system. The secondary aims were to characterize the risks of specific revision reasons between the tfn and the tfna and between the tfna blade and screw designs. The study sample comprised patients who underwent cephalomedullary nail fixation for hip fracture with a tfn (n
=
4,007) or tfna (n
=
3,972) from 2014 to 2019. The median age was 82 years (iqr, 74, 88 years). The following complications were reported as follows: tfn/tfna: 1,869 patients died at a median time of 1. 5 years. Tfn: revision reason: (n
=
44) fixation failure, (n
=
23) nonunion, (n
=
8) fracture, (n
=
1) infection, (n
=
2) implant breakage (1 was due to aperture failures related to the index fracture), and (n
=
43) cut-out. Tfna: revision reason: (n
=
41) fixation failure, (n
=
35) nonunion, (n
=
8) fracture, (n
=
2) infection, (n
=
5) implant breakage (3 were due to aperture failures related to the index fracture), and (n
=
33) cut-out. This report is for an unknown synthes tfn and tfna. A copy of the literature article is being submitted with this medwatch.
 
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Brand NameUNK - CONSTRUCTS: TFN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14250471
MDR Text Key290446635
Report Number2939274-2022-01538
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 Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - CONSTRUCTS: TFN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
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? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
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