MAUDE Adverse Event Report: PARAGON 28, INC. APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM; APEX 3D TIBIA, ARC, LEFT, SIZE 3, STANDARD, 3DP

Model Number P10-100-BL3S-S

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record for lot number or9j0j5 was reviewed and shows all inspected part were received and accepted.No ncr identified on dhr.During the returned product inspection, laser marking was confirmed incorrect on this part.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

During a surgical procedure on (b)(6) 2021, it was discovered that a paragon 28 apex 3d¿ tibia, arc, left, size 3, standard, 3dp was labeled incorrectly.The laser mark indicating size was marked incorrectly.The implant was labeled as 3l instead of 3s on the front of the implant.The complaint initiator confirmed that the implant was not used however, this malfunction is related to a violation of fda regulation.The surgeon used a different implant for the case.

• Brand Name: APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM
• Type of Device: APEX 3D TIBIA, ARC, LEFT, SIZE 3, STANDARD, 3DP
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112
• MDR Report Key: 11532867
• MDR Text Key: 243744011
• Report Number: 3008650117-2021-00059
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P10-100-BL3S-S
• Device Catalogue Number: P10-100-BL3S-S
• Device Lot Number: OR9J0J5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 60 YR