MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 160177

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been 01 other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

We noticed that blue foot for tibia impactor is starting to show wear while putting trays together in cpd.No associated procedure.

Event Description

We noticed that blue foot for tibia impactor is starting to show wear while putting trays together in cpd.No associated procedure.

Manufacturer Narrative

An event regarding wear involving a mako impactor was reported.It was reported that the tibia impactor was starting to wear.The device was not returned.Visual inspection of the received image noted that the device is worn on the proximal side near the edges.The device was discovered during inspection.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7773242
• MDR Text Key: 117014377
• Report Number: 3005985723-2018-00480
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 160177
• Device Lot Number: 19441216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other