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

Model Number ED-07827

Device Problem Device Fell (4014)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that metal portion of the identity impactor handle fell off after it had just been used with the tibia brooch.The surgeon successfully completed the surgery by covering the femoral and tibial components for protection and impacted them with the mallet.There were no adverse consequences to the patient.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that metal portion of the identity impactor handle fell off after it had just been used with the tibia brooch.The surgeon successfully completed the surgery by covering the femoral and tibial components for protection and impacted them with the mallet.There were no adverse consequences to the patient.

• Brand Name: ITOTAL IMPACTOR HANDLE
• 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: 11667958
• MDR Text Key: 247678418
• Report Number: 3004153240-2021-00047
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170226
• 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: 04/13/2021

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: ED-07827
• Device Lot Number: G190901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/14/2021
• 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