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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
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: TFN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
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).Additional narrative: complainant part is not expected to be returned for manufacturer review/ investigation.This report is for an unk constructs: tfn/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 h., et al (2019) rates of revision fixation between synthes trochanteric fixation nail (tfn) and trochanteric fixation nail advanced (tfna) in a u.S.Hip fracture database: analysis of 7,979 cases, bone jt surg.Volume 101 (9), pages 804-811 (usa).This retrospective study aims to compare revision rick for tfna to tfn in the treatment of hip fractures.From 2014-2019, a total of 7,979 patients undergoing treatment of hip fractures with cmn were included in this study.(n=4007) patients were treated with tfn and (n=3972) patients with tfna.The following complications were reported: cause of revision after surgical repair for hip fracture by cmn type: tfn 88 all cause, 45 fixation failure, 24 non-union, 15 peri-implant fracture, 3 infection, 46 cut-through/cut out, 9 lateral screw /blade prominence/migration, 2 implant breakage.Cause of revision after surgical repair for hip fracture by cmn type: tfna.82 all cause, 43 fixation failure, 37 non-union, 11 peri-implant fracture, 2 infection, 6 implant breakage.Cause of revision after surgical repair for hip fracture by tfna design: all cause: (n=62) blade and (n=20) screw.Cut through/cut out: 26 blade and 9 screws.11 lateral screw /blade prominence/migration.This report is for an unknown synthes tfn and tfna.This report is for (1) unk constructs: tfn.This is report 1 of 10 for complaint (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: goodnough h., et al (2019) rates of revision fixation between synthes trochanteric fixation nail (tfn) and trochanteric fixation nail advanced (tfna) in a u.S.Hip fracture database: analysis of 7,979 cases, bone jt surg.Volume 101 (9), pages 804-811 (usa).This retrospective study aims to compare revision rick for tfna to tfn in the treatment of hip fractures.From 2014-2019, a total of 7,979 patients undergoing treatment of hip fractures with cmn were included in this study.(n=4007) patients were treated with tfn and (n=3972) patients with tfna.The following complications were reported: cause of revision after surgical repair for hip fracture by cmn type: tfn 88 all cause, 45 fixation failure, 24 non-union, 15 peri-implant fracture, 3 infection, 46 cut-through/cut out, 9 lateral screw /blade prominence/migration, 2 implant breakage.Cause of revision after surgical repair for hip fracture by cmn type: tfna.82 all cause, 43 fixation failure, 37 non-union, 11 peri-implant fracture, 2 infection, 6 implant breakage.Cause of revision after surgical repair for hip fracture by tfna design: all cause: (n=62) blade and (n=20) screw.Cut through/cut out: 26 blade and 9 screws.11 lateral screw /blade prominence/migration.This report is for an unknown synthes tfn and tfna.This report is for (1) unk constructs: tfn.This is report 1 of 10 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.This report is for an unk constructs: tfn/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.
 
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Brand Name
UNK - CONSTRUCTS: TFN
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12838048
MDR Text Key285985071
Report Number2939274-2021-06742
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
Reporter Occupation Physician
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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