MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL STD LM/RL SIZE 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170505

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

Screw hole stripped on femoral trial.Case type: pka.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mako trial was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection and material analysis: an inspection of the returned device by a materials analyst noted "damage observed on threads consistent with crossthreading and off axis loading.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: n 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 similar reported events for the reported lot.Conclusions: no further investigation is required at this time.The root cause determined because insufficient information was provided.Further information such as operative notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

Screw hole stripped on femoral trial.Case type: pka.

• Brand Name: FEMORAL TRIAL STD LM/RL SIZE 5
• 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: 7958383
• MDR Text Key: 123505642
• Report Number: 3005985723-2018-00580
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003500
• UDI-Public: 00848486003500
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170505
• Device Lot Number: 26010911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Date Manufacturer Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other