MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC DARCO SYSTEM; PLATE, FIXATION, BONE

Model Number DCS2832020

Device Problems Nonstandard Device (1420); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted in patient.

Event Description

An osteotomy of the toe was performed on a patient with a bunion.When the plate was fastened, it was noticed that two of the four locking holes were not threaded, and the locking screws could not be used.The plate was used as it was without replacement, but the two holes were fixed with a non-locking screw, and the surgery was completed.

Event Description

An osteotomy of the toe was performed on a patient with a bunion.When the plate was fastened, it was noticed that two of the four locking holes were not threaded, and the locking screws could not be used.The plate was used as it was without replacement, but the two holes were fixed with a non-locking screw, and the surgery was completed.

Manufacturer Narrative

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.The reported event could not be confirmed since the device was not returned for evaluation.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.A inspection of the received picture has shown, that it is in a poor black/white quality.Based on this we are not able to do any statement.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.

• Brand Name: DARCO SYSTEM
• Type of Device: PLATE, 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13239359
• MDR Text Key: 285992769
• Report Number: 3010667733-2022-00014
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00840420112101
• UDI-Public: 00840420112101
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCS2832020
• Device Catalogue Number: DCS2832020
• Device Lot Number: 1696607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1