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); Detachment Of Device Component (1104); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded and was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Anterior corner of trial broke off when surgeon attempted to remove with coker.Trial had been improperly inserted and normal trial removal tool was ineffective.

Manufacturer Narrative

An event regarding crack/fracture involving an mako trial was reported.The event was confirmed.Method & results: -device evaluation and results: although the device was not returned for evaluation but a provided image shows anterior corner of trial broke off during removal with coker.-medical records received and evaluation: not performed as patient factors did not 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 image provided confirms the event that the anterior corner of trial broke off.The exact root cause could not be determined because the device was not returned for evaluation.If the device is received, this investigation will be reopened and re-evaluated.

Event Description

Anterior corner of trial broke off when surgeon attempted to remove with coker.Trial had been improperly inserted and normal trial removal tool was ineffective.

• 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: 5851110
• MDR Text Key: 52398439
• Report Number: 3005985723-2016-00237
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• 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: 12120512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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