MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 4-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170704-1

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report.

Event Description

The surgeon was trying to remove the poly trail with the extraction tool and a piece of the poly trail broke off.We were able to find the piece and this cause no patient harm.

Manufacturer Narrative

An event regarding crack/fracture involving a mako trail was reported.The event was confirmed.Method & results: -device evaluation and results: there are scratches in various areas of the trial and a large piece was missing from the right side of the trial.The holes are damage with use of the instrument over a period of time.Examination of the returned device with material analysis engineer noted the fracture occurred due to an overload condition as indicated by hackles observed on the fracture surface.-medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been 1 other event for the lot referenced.Conclusions: a visual inspection confirms the event.There are scratches in various areas of the trial and a large piece was missing from the right side of the trial.It was determined by an examination by an mar engineer that the fracture occurred due to an overload condition as indicated by hackles observed on the fractured service.If additional information becomes available, this investigation will be reopened.

Event Description

The surgeon was trying to remove the poly trail with the extraction tool and a piece of the poly trail broke off.We were able to find the piece and this cause no patient harm.A replacement part has already been ordered.(b)(4).Surgical delayed for: 5 min.

• Brand Name: TIBIAL INSERT ONLAY TRIAL-SIZE 4-8MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6132371
• MDR Text Key: 61032929
• Report Number: 3005985723-2016-00404
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170704-1
• Device Lot Number: 12720315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other