MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL CR TIBIAL TRAY IMPACTOR TIP; REUSABLE IMPLACTOR COMPONENT

Catalog Number ED-04258

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tibial insert impactor broke off inside the impactor handle, rendering the handle as unusable.The case was completed successfully.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the tibial insert impactor broke off inside the impactor handle, rendering the handle as unusable.The case was completed successfully.

• Brand Name: ITOTAL CR TIBIAL TRAY IMPACTOR TIP
• Type of Device: REUSABLE IMPLACTOR COMPONENT
• 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: thomas haueter ; 600 technology park drive; billerica, MA 01821 ; 7813459161
• MDR Report Key: 8245759
• MDR Text Key: 133185950
• Report Number: 3004153240-2019-00029
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ED-04258
• Device Lot Number: D142401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2018
• 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
• Patient Age: 80 YR