MAUDE Adverse Event Report: MAKO SURGICAL CORP. ONLAY INSERT EXTRACTOR; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 160430

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.Visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a mako extractor.From the photographs provided there is evidence that the device is in a used condition and the pins appear to be bent inward.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

Inlay insert extractor bent.Pka case.

Manufacturer Narrative

Correction: the reported event does not fall into the scope of the recall.An event regarding damage involving a mako extractor was reported.The event was confirmed.Confirmed: through photographs provided.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a mako extractor.From the photographs provided there is evidence that the device is in a used condition and the pins appear to be bent inward.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact root cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Inlay insert extractor bent.Pka case.

• Brand Name: ONLAY INSERT EXTRACTOR
• 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: 7658376
• MDR Text Key: 113015622
• Report Number: 3005985723-2018-00397
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486020644
• UDI-Public: 00848486020644
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160430
• Device Lot Number: 26201111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: PFA# 1657945
• Patient Sequence Number: 1
• Patient Outcome(s): Other