MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR SCREW 5.0MM X 35MM LEN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	4151150035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Implant Pain (4561)
Date of Event	01/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's rod broke, ultimately leading to the loss of his leg.He had an ankle breakage that required a rod implant on (b)(6) 2023.After a fall on (b)(6) 2024, the patient experienced pain, and x-rays in february confirmed the rod was broken.The rod was removed on (b)(6) 2024, and an amputation below the knee followed on (b)(6) 2024.The infection causing the amputation was not identified until the surgeon returned two weeks post-surgery.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction to h6(method code) the reported event could be confirmed since information provided through radiographic images and medical records matches with the alleged failure mode.Upon further investigation of the ct scans by healthcare professionals the following was observed: the x-ray do not only show and thus confirm the trimalleolar fracture, but they also show, that the patient has a charcot-foot situation.Obesity and diabetes with a polyneuropathy are described.All these factors increase the risk of a failure substantially.The choice for a nail to address the fracture is rather unusual and can only be explained by the individual risk, that the patient had due to the addition of these factors.I did not find a direct information regarding the infection.However, the sequence of events would fit very well with a non-union, loosening in the context of an infection.The risk for an infection is several times higher compared to a healthy patient.A microbiologist reviewed the sterilization procedures, environmental monitoring, bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications and was sterilized according to procedure.No deviations or non-conformances could be found.The root cause of the infection could not be conclusively determined.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 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient's rod broke, ultimately leading to the loss of his leg.He had an ankle breakage that required a rod implant on (b)(6) 2023.After a fall on (b)(6) 2024, the patient experienced pain, and x-rays in february confirmed the rod was broken.The rod was removed on (b)(6) 2024, and an amputation below the knee followed on (b)(6) 2024.The infection causing the amputation was not identified until the surgeon returned two weeks post-surgery.

• Brand Name: VALOR SCREW 5.0MM X 35MM LEN
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20242178
• Report Number: 3010667733-2024-00612
• Device Sequence Number: 7235153
• Product Code: HSB
• UDI-Device Identifier: 00840420115805
• UDI-Public: (01)00840420115805(11)230609(17)310609(10)1744869
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 4151150035
• Device Lot Number: 1744869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• 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: Disability
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 150 KG