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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 95MM STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 95MM STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.038.295S
Device Problem Migration (4003)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. 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
It was reported on (b)(6) 2019 the patient underwent an open reduction and internal fixation (orif) of the right femur to replace trochanteric femoral nail advance (tfna) blade. The tfna helical blade was protruding past the lateral femoral cortex and protruding minimally into the femoral head causing patient discomfort. Originally, the patient was treated with a 90 mm helical blade for a hip fracture on (b)(6) 2018. The fracture had healed; the helical blade was protruding laterally about 20mm and penetrating the femoral head less than 5mm due to fracture compression. The blade was replaced with a 75 mm helical blade without incident. Concomitant devices reported: tfna nail (part/lot unknown, quantity 1); screws (part/lot unknown, quantity unknown). This report is for a tfna helical blade. This is report 1 of 1 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE 95MM 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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8400231
MDR Text Key138123465
Report Number2939274-2019-56861
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,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.295S
Device Catalogue Number04.038.295S
Device Lot NumberH549086
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 Received04/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2018
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: 03/07/2019 Patient Sequence Number: 1
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