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

Catalog Number 111140

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

During a pka the slaphammer threads worn and missing the blue tip for impactor.

Manufacturer Narrative

Additional information: product available to stryker; device evaluated by mfg; an event regarding wear involving a mako instrument was reported.It was reported that slaphammer threads worn.The event could not be determined because device was not returned for evaluation.The damaged device was discovered during inspection.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 and/or devices become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

During a pka the slaphammer threads worn and missing the blue tip for impactor.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6847111
• MDR Text Key: 85612462
• Report Number: 3005985723-2017-00429
• Device Sequence Number: 1
• Product Code: NPJ
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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