MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 160177

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

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

Broken impactor found before case started.Case type: tka.

Manufacturer Narrative

An event regarding crack/fracture involving a mako impactor was reported.The event was confirmed from photograph supplied.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.Visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a fractured impactor head, nothing else could be determined from the photograph supplied -functional and dimensional inspections could not be performed as the device was not returned.-clinician review: 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: it was reported that the impactor head was fractured and the cause was not established.No product was returned for evaluation.The event was discovered prior to any procedure.There was no patient involvement with the reported event.This event meets the definition of preventive maintenance.Product surveillance will continue to monitor for trends.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that pr was raised on 15-dec-2017 due to complaint trend analysis 1053 was performed for mck tibial baseplate impactor head and found that the observed complaint rate of 590 +/- 270 is within the predicted complaint rate of an o4 documented in the risk management file.Although the observed complaint rate is conforming to the risk management file, the complaint trend review board determined that trend warrants further investigation and a preventative nc & capa shall be opened which is the purpose of this record.

Event Description

Broken impactor found before case started.Case type: tka.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8412714
• MDR Text Key: 138550228
• Report Number: 3005985723-2019-00216
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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: 160177
• Device Lot Number: 19730617
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/08/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other