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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2939274-2022-01115
• Device Sequence Number: 17235225
• Product Code: HSB
• UDI-Device Identifier: 10886982099266
• UDI-Public: 10886982099266
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.7MM CANNULATED LOCKING SCREW 38MM; 9/130 DEG TI CANN TFNA 235/LEFT - SILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 66 KG