MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.038.295

Device Problem Migration (4003)

Patient Problem Ulcer (2274)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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 (b)(6) 2022, the tfna hardware was removed due to the implant failing.The implant had cut through and had created an ulcer on the patient¿s lateral side.The implant was intact and no fragments were created.The patient was revised with a total hip arthroplasty (tha).This report involves one (1) tfna helical blade 95mm.This is report 1 of 3 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 95MM
• Type of Device: ROD, 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13940047
• MDR Text Key: 288122164
• Report Number: 2939274-2022-01115
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099266
• UDI-Public: 10886982099266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.295
• Device Catalogue Number: 04.038.395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• 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
• Treatment: 3.7MM CANNULATED LOCKING SCREW 38MM; 9/130 DEG TI CANN TFNA 235/LEFT - SILE
• Patient Outcome(s): Required Intervention
• Patient Weight: 66 KG