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

Model Number	415101015L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	12/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Additional devices listed in this report: cat 4151150070 alor screw 5.0mm x 70mm lot code 1652714, cat 4151200003 valor nail end cap lot code 1628208, cat 4151150085 valor screw 5.0mm x 85mm lot code 1612487, cat 4151150030 valor screw 5.0mm x 30mm lot code 1641561, cat 4151150035 valor screw 5.0mm x 35mm lot code 1645318, cat 4151150030 valor screw 5.0mm x 30mm lot code 1641562, cat 4151150025 valor screw 5.0mm x 25mm lot code 1648001.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the devices are not available for evaluation.
Event or Problem Description
It was reported via a product liability claim that the patient had an ankle nail and screws implanted.Sometime post-op the patient underwent a revision due to an infection.The patient apparently had an amputation due to the infection.
Event or Problem Description
It was reported via a product liability claim that the patient had an ankle nail and screws implanted.Sometime post-op the patient underwent a revision due to an infection.The patient apparently had an amputation due to the infection.
Additional Manufacturer Narrative
Correction h6 clinical code, method code based on the received information we can confirm that there was infection (staphylococcus aureus) in blood cultures the day of explantation.On this statement the complaint is confirmed.No further statement can be made, as we haven't received the affected device and no other evidence were provided.Medical profession reviewed the received information and noted: the accident caused an open fracture; this is the highest risk factor for an infection in general.After the implantation of the subject implants and use of instruments, the bloodwork showed no signs of an infection, nor does the documentation describe such an event.Healing problems with the bone, which are influenced by the severity of the trauma, and by nicotine abuse (smoker) as well, made re-operation(s) necessary.A review of the device history for the reported lot did not indicate any abnormalities.The sterilization records were also reviewed and conforms to specifications.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.Based on investigation and the information received, it is not possible to determine the root cause.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: VALOR NAIL
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13581744
• Report Number: 3010667733-2022-00098
• Device Sequence Number: 4410433
• Product Code: HWC
• UDI-Device Identifier: 00840420125484
• UDI-Public: 00840420125484
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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 Expiration Date: 09/20/2026
• Device Model Number: 415101015L
• Device Catalogue Number: 415101015L
• Device Lot Number: 1628229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG