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

Catalog Number 160177

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 03/04/2019

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 available.

Event Description

A piece of blue plastic broke off of the tibial bp impactor while impacting in the patient.Dr recovered all of the fragment and moved on.

Manufacturer Narrative

An event regarding crack/fracture involving a mako impactor was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.No photographs were provided for review.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 reported discrepancies.Complaint history review: there have been one other similar events for the lot referenced.Conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as product return and images of the device taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.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

A piece of blue plastic broke off of the tibial bp impactor while impacting in the patient.Dr recovered all of the fragment and moved on.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8470316
• MDR Text Key: 140536299
• Report Number: 3005985723-2019-00266
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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: 19010910
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other