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

Catalog Number 160177

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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

Using impactor for tibial baseplate on pka and the blue ¿pad¿ on the tibial impactor broke and fell off of the main body of the impactor.

Manufacturer Narrative

An event regarding crack/fracture involving a mako impactor was reported.The event was confirmed through visual inspection of the provided photographs.Method & results: product evaluation and results: the reported device was not returned however two photographs were provided for review.The photographs provided show the blue pad/foot section of the mako impactor.No photographs of the mako impactor body were provided.Catalog number 160177 and lot code 19030314 are visible on the blue pad/foot.Damage is visible on the blue foot/pad.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 blue ¿pad¿ on the tibial impactor broke and fell off of the main body of the impactor.The reported device was not returned however two photographs were provided for review.The photographs provided show the blue pad/foot section of the mako impactor.No photographs of the mako impactor body were provided.Catalog number 160177 and lot code 19030314 are visible on the blue pad/foot.Damage is visible on the returned section of the product.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as further information such as product return, images of the device taken when the alleged event was identified and operative report are 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

Using impactor for tibial baseplate on pka and the blue ¿pad¿ on the tibial impactor broke and fell off of the main body of the impactor.

• 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: 8038869
• MDR Text Key: 127359505
• Report Number: 3005985723-2018-00651
• 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: 01/08/2019

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 Catalogue Number: 160177
• Device Lot Number: 19030314
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other