MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33654406

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that there was a presence of hair in implant.

Manufacturer Narrative

The complaint is confirmed, as we have received back a open package with a hair for evaluation.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.The device inspection revealed the following: visual evaluation of the received product has shown that we have received a open carton package, furthermore also the outer sterile package is already opened.The reported hair we have found lying on the inner sterile package.The inner sterile package is still in a sealed and intact condition including the implant as it should.Also there is no hair visible inside the package.We are not able to confirm if the hair was packed and sealed in the outer package together with the inner package.If more information is provided, the case will be reassessed.

Event Description

It was reported that there was a presence of hair in implant.

• Brand Name: INFINITY¿ TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 13453136
• MDR Text Key: 285244934
• Report Number: 3010667733-2022-00036
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122780
• UDI-Public: 00840420122780
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

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
• Device Operator: Health Professional
• Device Model Number: 33654406
• Device Catalogue Number: 33654406
• Device Lot Number: 1677717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• 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