MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 100MM; ROD,FIXATION,INTRAMEDULLARY

Model Number 456.305

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting.Additional product code: hwc.Date of implant reported only as approximately six (6) weeks prior to removal.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 that approximately six weeks prior to removal, the patient was implanted with a short trochanteric fixation nail (tfn), helical blade, and distal locking screw for repair of a hip fracture.Patient later presented with hip pain.Subsequent x-ray taken on unknown date showed that the femoral head had collapsed and the helical blade was just starting to protrude through the femoral head.On (b)(6) 2018, the 100mm helical blade was removed and replaced with 85mm helical blade.However, the nail and distal locking screw remained implanted in the patient as there was no issue with these two (2) devices.No surgical delay or patient consequence was reported.The procedure was completed successfully.Concomitant devices reported: short tfn nail (part number unknown, lot number unknown, quantity 1); distal locking screw (part number unknown, lot number unknown, quantity unknown).This report is for one (1) 11.0mm helical blade 100mm.This is report 1 of 1 for (b)(4).

• Brand Name: 11.0MM TI 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7678234
• MDR Text Key: 113676277
• Report Number: 2939274-2018-52811
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982226716
• UDI-Public: (01)10886982226716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 456.305
• Device Catalogue Number: 456.305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR