MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR NAIL MD LT 11.5MMX200MM; SCREW, FIXATION, BONE

Model Number	415101120L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced redness and swelling lower leg and ankle.It was also noted that the im nail loosened and caused infection that led to a nonunion of the ankle fusion site.It required removal of the im nail with bone biopsies and placement of abx cement nail.In addition to that the patient was given iv antibiotics for 6 weeks followed with revision of ankle fusion with external fixator.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.

• Brand Name: VALOR NAIL MD LT 11.5MMX200MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13524844
• Report Number: 3010667733-2022-00074
• Device Sequence Number: 20154869
• Product Code: HWC
• UDI-Device Identifier: 00840420125583
• UDI-Public: 00840420125583
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 415101120L
• Device Catalogue Number: 415101120L
• 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: 01/17/2022
• Initial Report FDA Received Date: 02/14/2022
• 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; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 102 KG