MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 5-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170705-1

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available at the later time it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Tibial insert trial broke during impaction.

Manufacturer Narrative

An event regarding a fractured tibial insert onlay trial was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed since patient factors didn't contribute to the event.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 has been no other event for the lot referenced.Conclusions: the exact cause of the event could not be determined because the device was not returned for evaluation and insufficient information was provided.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Tibial insert trial broke during impaction.

• Brand Name: TIBIAL INSERT ONLAY TRIAL-SIZE 5-8MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5990281
• MDR Text Key: 56592519
• Report Number: 3005985723-2016-00308
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

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 Catalogue Number: 170705-1
• Device Lot Number: 12110809B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR