MAUDE Adverse Event Report: MAKO SURGICAL CORP. CEMENT REMOVAL TOOL; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	120095
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2018
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.
Event or Problem Description
The cement tool bent intraop.Case type: pka.
Event or Problem Description
The cement tool bent intraop.Case type: pka.
Additional Manufacturer Narrative
An event regarding damage involving a mako instrument was reported.The event was not confirmed.Visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.No medical records were received for review with a clinical consultant.Review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for this lot.It was reported that the cement removal tool bent during surgery.The event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CEMENT REMOVAL TOOL
• 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: 7797133
• Report Number: 3005985723-2018-00499
• Device Sequence Number: 13949589
• Product Code: NPJ
• UDI-Device Identifier: 00848486018092
• UDI-Public: 00848486018092
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• 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
• Report Date (Section B): 10/11/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 120095
• Device Lot Number: 06011109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/11/2018
• 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