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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 100MM STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 100MM STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.038.300S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
Patient identifier, weight, and ethnicity not available for reporting. Date of event: date of fracture is not known. Date of implant is not known. Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
It was reported that on (b)(6) 2018, patient underwent a removal of a trochanteric fixation nail advanced (tfna) due to a fracture that occurred at a point of a stress riser between the tfna nail and a variable angle (va) condylar plate. The tfna nail was easily removed and replaced with a new, longer tfna nail which extended beyond the plate. An unknown quantity of cables were also placed to augment the construct, as well as an unknown quantity of screws. No fragments were produced. It is not known if surgery was delayed. Patient outcome is not known. This report is for one (1) tfna helical blade 100mm. This is report 2 of 5 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE 100MM STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7782679
MDR Text Key117126643
Report Number2939274-2018-53327
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.038.300S
Device Catalogue Number04.038.300S
Device Lot Number9909005
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 Received09/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2015
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: 08/14/2018 Patient Sequence Number: 1
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