MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 160177

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The blue tip on the tibial impactor broke.After the surgeon impacted the tibial baseplate the blue tip was no longer staying on the impactor.No pieces were missing just need a replacement.

Event Description

The blue tip on the tibial impactor broke.After the surgeon impacted the tibial baseplate the blue tip was no longer staying on the impactor.No pieces were missing just need a replacement.

Manufacturer Narrative

An event regarding crack/fracture involving a mako impactor was reported.The event was not confirmed.Method & results: device evaluation and results: material, visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed because no medical records were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: it was reported that after the surgeon impacted the tibial baseplate the blue tip was no longer staying on the impactor and was found broken on the back table after the impactor was used.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7157871
• MDR Text Key: 96506040
• Report Number: 3005985723-2018-00001
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160177
• Device Lot Number: 19220210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other