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

Catalog Number 120095

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

The cement tool bent intraop.Case type: pka.

Event Description

The cement tool bent intraop.Case type: pka.

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
• 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: 7797133
• MDR Text Key: 117588890
• Report Number: 3005985723-2018-00499
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486018092
• UDI-Public: 00848486018092
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 120095
• Device Lot Number: 06011109
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other