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

Model Number 04.038.300

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient age, date of birth, gender, and weight not available for reporting.Date of device cut out is not known.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 patient was implanted with the trochanteric fixation nail advanced (tfna) nail, helical blade, and 5.0 mm locking screw on (b)(6) 2018.On unknown date an anterior cutout of the helical blade and femoral head collapse were detected.Patient was returned to surgery on (b)(6) 2018 where all hardware was removed.Patient was revised to a hip arthroplasty.Concomitant devices reported: 12 mm 130 degree titanium cannulated tfna nail 170 mm (04.037.242s, lot h464168, quantity 1), 5.0 mm locking screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) tfna helical blade 100 mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 04.038.300s, lot# h183655.Manufacturing location: elmira, manufacturing date: sep 29, 2016, expiry date: aug 31, 2026.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 100mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material 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.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.

• Brand Name: TFNA HELICAL BLADE 100MM
• 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: 7425848
• MDR Text Key: 105311759
• Report Number: 2939274-2018-51620
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099020
• UDI-Public: (01)10886982099020(17)260831(10)H183655
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.300
• Device Catalogue Number: 04.038.300
• Device Lot Number: H183655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Date Device Manufactured: 09/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention