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

Catalog Number 160177

Device Problems Break (1069); Fracture (1260)

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

Event Date 02/10/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the tip of the tibial impactor was broken into pieces while the surgeon was hammering the tibia inserter during the surgery.

Manufacturer Narrative

An event regarding crack/fracture involving an mako impactor was reported.The event was confirmed through pictures and material inspection of the returned device.Method & results: -device evaluation and results: a visual inspection of the returned device noted that the device was returned in used condition.The device was found to be broken in two pieces.Scratch and dent marks are observed on the surface of the device.Also material analysis was performed for the returned device which noted that fracture consistent with an overload condition as indicated by hackles observed on the fracture surface.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there have been 1 other events for the lot referenced.Conclusions: it was reported that the tip of tibial impactor was broken into pieces.A visual inspection of the returned device noted that the device was returned in used condition.The device was found to be broken into two pieces.Scratch and dent marks were observed on the surface of the device.A review of the device by a material engineer indicated that fracture consistent with an overload condition as indicated by hackles observed on the fracture surface.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the tip of the tibial impactor was broken into pieces while the surgeon was hammering the tibia inserter during the surgery.

• 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: 7333845
• MDR Text Key: 102218777
• Report Number: 3005985723-2018-00173
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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: 19070411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR