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

Catalog Number 160405

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

Bad condition.Case type: pka.Update: "the surgeon noticed the tip of the impactor was chipped/chipping.She asked that it be replaced".

Manufacturer Narrative

H1 type of reportable event initial mistakenly reported as serious injury, correcting to malfunction.An event regarding damage involving a mako impactor was reported.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 similar events for the lot referenced.Conclusion: no product was returned for evaluation.The device was discovered prior to medical procedure.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 the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Bad condition.Case type: pka.Update: "the surgeon noticed the tip of the impactor was chipped/chipping.She asked that it be replaced".

• Brand Name: IMPACTOR-ONLAY INSERT
• 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: 8934921
• MDR Text Key: 155646721
• Report Number: 3005985723-2019-00602
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486003203
• UDI-Public: 00848486003203
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160405
• Device Lot Number: 12080111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other