MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 3-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170703-1

Device Problems Break (1069); Crack (1135); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was misplaced and was not returned to the manufacturer.Additional information has been requested.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

The poly cracked while it was being removed during the trialing process.

Manufacturer Narrative

An event regarding crack/fracture involving a tibial insert onlay trial-size 3-8mm was reported.The event was confirmed.The device was not returned.Inspection of the blurry photos confirms that the trial had fractured and there appears to be worn/damaged on the edges.Not performed as medical records were not provided for 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 1 other event for the lot referenced.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the instrument are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

The poly cracked while it was being removed during the trialing process.

• Brand Name: TIBIAL INSERT ONLAY TRIAL-SIZE 3-8MM
• 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: 5242367
• MDR Text Key: 31804312
• Report Number: 3005985723-2015-00273
• 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: 11/04/2015

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 Expiration Date: 05/30/2016
• Device Catalogue Number: 170703-1
• Device Lot Number: 12170312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2011
• 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