MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 111140

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events, there have been three other events for the reported lot which also relate to the crack/fracture of a slap hammer.

Event Description

As reported: "femoral impactor thread broke off in trial".Issue reported during impaction.Case type: pka.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8045893
• MDR Text Key: 127352744
• Report Number: 3005985723-2018-00655
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486002732
• UDI-Public: 00848486002732
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2018

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: 111140
• Device Lot Number: 06060515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other