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

Model Number	04.038.400S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event date is unknown.Additional product code :ktt.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.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.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 on (b)(6) 2021, the patient underwent removal of proximal femoral nailing system (tfna) nail, tfna fenestrated helical blade and titanium locking screw due to migration of unknown implant and the surgeon said it was beginning to cut out.The patient outcome was unknown.Concomitant device reported: unknown nail ( part # 04.037.156s, lot# unknown, quantity 0).Unknown locking screws (part# 04.005.532, lot# unknown, quantity 0).This complaint involves one (1) device.This report is for (1) tfna fenestrated helical blade 100 -s.This report is 1 of 1 (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 100 -S
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11660379
• Report Number: 2939274-2021-01832
• Device Sequence Number: 3498228
• Product Code: HSB
• UDI-Device Identifier: 10886982099297
• UDI-Public: (01)10886982099297
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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: 04.038.400S
• Device Catalogue Number: 04.038.400S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention