MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 170706-1

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been two other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

As reported: "products 170706-1 were ordered and what is listed on the packaging but products 170604 lot code 26080916 were what was inside the packaging".

Manufacturer Narrative

An event regarding product mix involving a mako baseplate trial was reported.The event was confirmed.The products were returned with the packaging.Two baseplate trials were returned, catalog 170604 lot 26080916.The trials were in new condition.Both baseplate trials had catalog #170604 on device with package labels for insert trials, catalog 170706-1 lot number 12371116.Medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.There has been 7 other events for the lot indicated.The investigation confirmed the reported event of a product mix between the trial baseplate and trial insert.Nc was issued on (b)(6) 2017 for the product mix.The nc determined the root cause of this event was a lack of standard work where personnel did not perform proper line clearance due to a lack of training.

Event Description

As reported: "products 170706-1 were ordered and what is listed on the packaging but products 170604, lot code 26080916 were what was inside the packaging".

• Brand Name: TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM
• 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: 7354584
• MDR Text Key: 103279186
• Report Number: 3005985723-2018-00180
• 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: 04/18/2018

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: 170706-1
• Device Lot Number: 12371116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other