MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR NAIL MD LT 10MM X 200MM; SCREW, FIXATION, BONE

Catalog Number	415101020L
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Italian distributor waldner reported that a valor nail was removed in abano on wednesday 8th.The nail broke 7 years after implantation.The break point corresponds to the hole for the subtalar screw that had not been placed.Unanticipated medical procedure.
Additional Manufacturer Narrative
Corrected fields: product available to stryker (d9) and reporting contact (g1).The reported event could be confirmed since an image was provided and matches the alleged failure mode.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned.However, an image provided for examination shows the valor nail is visibly fractured into two pieces with the breakage occurring at the hole for the subtalar screw.Significant scratches can be seen around the fracture site.A healthcare professional reviewed the received information and noted the following: in general, the nail is not foreseen to take over the load for a longer period of time.It is usually supposed to provide stability until the bone is united.This usually happens depending on the indication and the specific pathology after 6 weeks to 12 months-even in the very complex situation we have like in charcot patients.After that period the nail should become inactive.Therefore, i would say, that the failure here seems to have occurred due to either a non-union with the nail having provided stability for an extraordinary long period of time or, that, after initial consolidation a secondary instability of the situation has occurred.The missing screw may have contributed to the failure.Based on investigation, the root cause was attributed to a user related issue.The failure was most likely caused by failure to place the subtalar screw during the primary surgery which would have provided additional stability and reduced stress concentration at the screw hole.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The operative technique was reviewed and states: the subtalar screw provides stability to the talo-calcaneal joint by fixating the talar and calcaneal bodies through the valor nail.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Italian distributor waldner reported that a valor nail was removed in abano on wednesday 8th.The nail broke 7 years after implantation.The break point corresponds to the hole for the subtalar screw that had not been placed.Unanticipated medical procedure.

• Brand Name: VALOR NAIL MD LT 10MM X 200MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21342989
• Report Number: 3010667733-2025-00131
• Device Sequence Number: 13043276
• Product Code: HWC
• UDI-Device Identifier: 00840420125507
• UDI-Public: (01)00840420125507(11)150101(17)230101(10)1551795
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Expiration Date: 01/01/2023
• Device Catalogue Number: 415101020L
• Device Lot Number: 1551795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2015
• 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 Sex: Unknown