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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 90MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.038.190
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional device product code: ktt. (b)(4). The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 october 22, 2020, the patient underwent removal of a proximal femoral nailing system (tfna) due to tfna fenestrated screw broke in the thread. During the procedure the tfna nail, fenestrated screw and a distal locking screw were removed successfully without further damage and the patient was revised to a bipolar hip. The femur split during implantation of bipolar hip and a cerclage cable was used to stabilize the femur and implant. The procedure was successfully completed. The patient's status is unknown. Concomitant device reported: tfna nail (part #: 04. 037. 242, lot #: h607959, quantity: 1), unknown locking screw (part #: unknown, lot #: unknown, quantity: 1). This report is for one (1) tfna fenestrated screw 90mm. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameTFNA FENESTRATED SCREW 90MM
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 (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 Key10869471
MDR Text Key217161609
Report Number2939274-2020-05235
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982098726
UDI-Public(01)10886982098726
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.190
Device Catalogue Number04.038.190
Device Lot Number17P3920
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2019
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: 11/19/2020 Patient Sequence Number: 1
Treatment
12MM/130 DEG TI CANN TFNA 170MM - STERILE; UNK - SCREWS: LOCKING
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