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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 110MM STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 110MM STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.038.310S
Device Problem Migration (4003)
Patient Problems Discomfort (2330); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Date of implantation is an unknown date in (b)(6) 2017. Complainant part is not expected to be returned for manufacturer review/investigation. Date of concomitant therapy is the same as date of implantation, an unknown date in (b)(6) 2017. Part: 04. 038. 310s; lot: h261199; part manufacturing date: january 20, 2017; manufacturing site: elmira; part expiration date: december 31, 2026; nonconformance noted: n/a a review of the device history record revealed no complaint related anomalies. The device history record shows lot h261199 of tfna helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted. This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record(s) determined the raw material lot h077914 met all specifications with no issues documented that would contribute to this complaint condition. Product was not returned. Based on the information available, it has been determined that no corrective and 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. (b)(4). 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 an unknown date, the patient underwent hardware removal of trochanteric fixation nail advanced (tfna) implants due to discomfort in the operative hip. The helical blade implant had cut-out into the acetabulum, causing irritation. Patient was revised to total hip arthroplasty. Tfna hardware was originally implanted in (b)(6) 2017. Procedure outcome and patient status are unknown. Concomitant devices: 5. 0mm titanium (ti) locking screw-sterile (part: 04. 005. 528s, lot: h329932, quantity: 1), 10mm/130 degree ti cannulated tfna nail (part: 04. 037. 042s, lot: h346500, quantity 1). 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 110MM 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 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7947857
MDR Text Key123107439
Report Number2939274-2018-54265
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
Type of Report Initial
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.038.310S
Device Catalogue Number04.038.310S
Device Lot NumberH261199
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 Received09/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2017
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: 10/09/2018 Patient Sequence Number: 1
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