MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. VALOR NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	4151150075
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to treat a tri-malleolar fracture with a hindfoot nail.The posterior calcaneus screw was revised as it had backed out of the nail.The same screw was re-inserted through the nail and an end cap was used to prevent the screw from backing out again.After the surgeon inserted the end cap, he wanted to advance the posterior screw a little further which he was able to with the end cap on.He then tested to see that the end cap was working and could not back-out the posterior screw with the end cap on.

• Brand Name: VALOR NAIL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12790617
• Report Number: 0001043534-2021-00221
• Device Sequence Number: 19801968
• Product Code: HSB
• UDI-Device Identifier: 00840420115843
• UDI-Public: 00840420115843
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: Lay User/Patient
• Device Model Number: 4151150075
• Device Catalogue Number: 4151150075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59
• Patient Sex: Male
• Patient Weight: 105 KG