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); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

The impactor tip chipped during implant impaction.Both pieces were located, and are not in the joint.The blue tip chipped in to two pieces.

Event Description

The impactor tip chipped during implant impaction.Both pieces were located, and are not in the joint.The blue tip chipped in to two pieces.

Manufacturer Narrative

An event regarding crack/fracture involving a mako impactor was reported.The event was confirmed through inspection by the material analysis engineer.Method & results: -product evaluation and results: the material analysis engineer indicated, "that the device is worn due to in service use consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." -clinician review: no medical records were received for review with a clinical consultant.-product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the trial insert broke during use.Inspection performed by a material analysis engineer indicated that "the device is worn due to in service use consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." no further investigation is required at this time.If additional information becomes 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: 8039328
• MDR Text Key: 127353631
• Report Number: 3005985723-2018-00652
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• 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: 12040317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other