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

Catalog Number 160430

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

Stryker has initiated a voluntary, lot specific recall for the mako onlay insert extractor which has not been assigned an fda reference number.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

Rep reported that on sales branch advice, all sets were inspected and a second instrument was found rusted.No associated procedure.

Manufacturer Narrative

An event regarding corrosion involving a mako extractor was reported.The device was discovered during inspection.The product was not returned for evaluation.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Rep reported that on sales branch advice, all sets were inspected and a second instrument was found rusted.No associated procedure.

• 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: 7622337
• MDR Text Key: 112445516
• Report Number: 3005985723-2018-00383
• 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: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

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: 160430
• Device Lot Number: 19110915
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2051-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other