MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL TIBIAL IMPACTOR TIP; KNEE ARTHROPLASTY IMPLANTATION SYSTEM

Catalog Number ED-08155

Device Problem Break (1069)

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

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tibial impactor tip broke on the final impaction of the tibial baseplate.The surgery continued as planned.There were no adverse effects to the patient.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the tibial impactor tip broke on the final impaction of the tibial baseplate.The surgery continued as planned.There were no adverse effects to the patient.

• Brand Name: ITOTAL TIBIAL IMPACTOR TIP
• Type of Device: KNEE ARTHROPLASTY IMPLANTATION SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: emmanuel nyakako ; 600 technology park drive; billerica, MA 01821 ; 7813459164
• MDR Report Key: 11298390
• MDR Text Key: 231991027
• Report Number: 3004153240-2021-00009
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ED-08155
• Device Lot Number: A202101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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