MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 160177

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Intra-op tibial tray impactor had a crack in it and is no longer usable.

Manufacturer Narrative

An event regarding crack/fracture involving an mako impactor was reported.The event was confirmed through device image.Method & results: -device evaluation and results: the device was not returned however, an image was provided showing that the device is fractured along the inferior side of the tip.-medical records received and evaluation: no medical records were received for review with a clinical consultant -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been two other similar events for the reported lot.Conclusions: the device was not returned however, an image was provided confirming the reported event; reason not stablished.The tip of the impactor is fractured along from one end to the other side.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Intra-op tibial tray impactor had a crack in it and is no longer usable.

Manufacturer Narrative

Corrected data: d/4 - device information was updated.An event regarding crack/fracture involving an mako impactor was reported.The event was confirmed through device image.Method & results: device evaluation and results: the device was not returned however, an image was provided showing that the device is fractured along the inferior side of the tip.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been two other similar events for the reported lot.Conclusions: the device was not returned however, an image was provided confirming the reported event.The tip of the impactor is fractured along from one end to the other side.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Intra-op tibial tray impactor had a crack in it and is no longer usable.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• 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: 8112861
• MDR Text Key: 128910999
• Report Number: 3005985723-2018-00696
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003128
• UDI-Public: 00848486003128
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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: 19280316
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other