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

Model Number 415101020R

Device Problem Failure to Advance (2524)

Patient Problem Failure of Implant (1924)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

Device not returned at time of this report.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the internal compression screw could not be turned and removed.The surgeon removed the implant and inserted a new implant which extended the surgery time as well as tourniquet time and extra holes in the bone.No additional patient complications were reported.

Event Description

It was reported that the internal compression screw could not be turned and removed.The surgeon removed the implant and inserted a new implant which extended the surgery time as well as tourniquet time and extra holes in the bone.No additional patient complications were reported.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.No indications of material, manufacturing or design related problems were found during the investigation.The operative technique was reviewed: "back off the internal compression screw using the 4.0mm hex driver", "while optional, the end cap prevents the intrusion of bone and soft-tissues into the nail, thereby making removal easier." if the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: VALOR NAIL
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 11889290
• MDR Text Key: 257714543
• Report Number: 0001043534-2021-00090
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00840420125514
• UDI-Public: 00840420125514
• Combination Product (y/n): N
• PMA/PMN Number: K082320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 415101020R
• Device Catalogue Number: 415101020R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1