MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. VALOR NAIL; SCREW, FIXATION, BONE

Model Number	415101015L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient had pain sometime post-op and went to see the surgeon.It was found that the nail had snapped in half.The patient underwent a revision surgery.
Event or Problem Description
It was reported that the patient had pain sometime post-op and went to see the surgeon.It was found that the nail had snapped in half.The patient underwent a revision surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.The current package insert lists "fracture of implant" as a potential complication.It also states, ¿abnormal or excessive forces could lead to delayed union, non-union, or failure of the implant.Abnormal force loading and subsequent wear may be caused by: uncorrected instability; improperly sized implant; inadequate soft tissue support; implant malposition; excessive motion; uncorrected or recurrent deformity; or patient misuse or overactivity.¿ 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.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: VALOR NAIL
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 11824701
• Report Number: 0001043534-2021-00081
• Device Sequence Number: 14430656
• Product Code: HWC
• UDI-Device Identifier: 00840420125484
• UDI-Public: 00840420125484
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 415101015L
• Device Catalogue Number: 415101015L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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
• Patient Age: 62 YR