MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR NAIL DRIVER STAR 25; DRIVER, PROSTHESIS

Catalog Number	4150003001
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "when screwing in the calcaneus screw, the screwdriver broke off at the tip.".
Additional Manufacturer Narrative
Correction: please refer to section h6 health impact code.The complaint could be confirmed, since the information for evaluation matches the alleged failure.The investigation revealed the following: an inspection of the images has shown that indeed the star recess tip got twisted off right at the section from the star recess and shank.At the broken off part are deformation from tighten are visible.Otherwise, no further statement are possible based on this image, for further evaluation it is needed to receive the screw driver and the broken off part.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.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when screwing in the calcaneus screw, the screwdriver broke off at the tip." 4/8/2025 - additional information received: it was average hard bone.Approximately 60 minutes delay until the screw was inserted appropriately.No consequences for the patient.Fortunately, there was no debris.Reaming of the drill hole and insertion of the screw under constant x-ray control.

• Brand Name: VALOR NAIL DRIVER STAR 25
• Common Device Name: DRIVER, PROSTHESIS
• 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: 21713239
• Report Number: 3010667733-2025-00383
• Device Sequence Number: 18630026
• Product Code: HWR
• UDI-Device Identifier: 00889797061384
• UDI-Public: (01)00889797061384(11)110803(10)873744
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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 Catalogue Number: 4150003001
• Device Lot Number: 873744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown