MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 110MM STERILE; ROD, FIXATION, INTRAMEDULLARY

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).

• Brand Name: TFNA HELICAL BLADE 110MM STERILE
• Type of Device: ROD, 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 Key: 7947857
• MDR Text Key: 123107439
• Report Number: 2939274-2018-54265
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099075
• UDI-Public: (01)10886982099075
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.310S
• Device Catalogue Number: 04.038.310S
• Device Lot Number: H261199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 132