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

Catalog Number	160430
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Inlay insert extractor bent.Pka case.
Additional 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 or Problem Description
Inlay insert extractor bent.Pka case.

• Brand Name: ONLAY INSERT EXTRACTOR
• 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: 7658376
• Report Number: 3005985723-2018-00397
• Device Sequence Number: 19464647
• Product Code: NPJ
• UDI-Device Identifier: 00848486020644
• UDI-Public: 00848486020644
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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: 160430
• Device Lot Number: 26201111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PFA# 1657945
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other