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

Catalog Number	160177
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Intra-op tibial tray impactor had a crack in it and is no longer usable.
Additional 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 or Problem Description
Intra-op tibial tray impactor had a crack in it and is no longer usable.
Additional 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 or Problem Description
Intra-op tibial tray impactor had a crack in it and is no longer usable.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Common Device Name: 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
• Report Number: 3005985723-2018-00696
• Device Sequence Number: 14044349
• Product Code: NPJ
• UDI-Device Identifier: 00848486003128
• UDI-Public: 00848486003128
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 160177
• Device Lot Number: 19280316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 02/25/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/17/2019; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other