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

Model Number	415101125L
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned at time of this report.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the compression screw did not work in the nail as the driver did not fin in the compression screw.The nail was removed and replaced with a different size nail.There was no impact to the patient.
Event or Problem Description
It was reported that the compression screw did not work in the nail as the driver did not fin in the compression screw.The nail was removed and replaced with a different size nail.The surgery was delayed 30 minutes.There was no impact to the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the device shows deformation and scratching in the internal recess of the nail where the compression screw is to be inserted.The device also exhibits normal wear found on a reusable device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The failure was caused due to improper usage of nail in previous surgeries.The ifu clearly instructs the user that: "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling", and "end of functional life is normally determined by wear and damage due to use." if any further information is provided, the complaint report will be updated.

• Brand Name: VALOR NAIL
• Common Device Name: SCREW, FIXATION, BONE
• 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: 11891251
• Report Number: 0001043534-2021-00093
• Device Sequence Number: 11612848
• Product Code: HWC
• UDI-Device Identifier: 00840420125606
• UDI-Public: 00840420125606
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: 415101125L
• Device Catalogue Number: 415101125L
• Device Lot Number: 1639385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2018
• 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
• Patient Sex: Unknown