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

Catalog Number 160430

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Poly extractor is noticeably rusted and no longer works when trying to take out the partial knee poly.Pka case.

Event Description

Poly extractor is noticeably rusted and no longer works when trying to take out the partial knee poly.Pka case.

Manufacturer Narrative

An event regarding non-functional involving a onlay insert extractor was reported.The event was not confirmed by functional test.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 20-jun-2018 which indicated, ¿energy dispersive spectroscopy (eds) analysis was performed on the leaf spring and adhered debris as shown in figures 8 and 9, respectively.Elemental constituents of the leaf spring included fe and cr; which is consistent with a 400 series stainless steel alloy.Elemental constituents of the adhered debris included o, fe, cr, ca, mg, p.The fe and cr is consistent with the leaf spring.The fe and o peaks are consistent with an iron oxide corrosion product.Ca, mg, and p are consistent with biological material.¿ a functional inspection was conducted on the returned device.When pressing the handles on the insert extractor they function as intended.The leaf springs collapse up toward the upper part of the device.The pins come together as intended.A material analysis has been performed.The report concluded: ¿the onlay insert extractor was observed to have in service wear and adhered debris.Eds showed that the leaf spring was consistent with a 400 series stainless steel alloy.The adhered debris on the leaf spring was consistent with iron oxide and biological material.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.¿ clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event for non-functional was not confirmed.Based on a functional test of the returned device the leaf springs were able to collapse as intended which protrude the pins that engages the trial insert.The leaf springs are rusted but do not interfere with the function of the device.

• 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: 7522280
• MDR Text Key: 108875886
• Report Number: 3005985723-2018-00300
• Device Sequence Number: 1
• Product Code: NPJ
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• 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: 19110915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: PFA# 1657945
• Patient Sequence Number: 1
• Patient Outcome(s): Other