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

Catalog Number 111140

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

Threads broke off in trial.

Manufacturer Narrative

Correction (08/29/2017): manufacturer entity.An event regarding crack/fracture involving an mako other instrument was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.

Event Description

Threads broke off in trial.

• 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: 6675606
• MDR Text Key: 78695115
• Report Number: 3005738134-2017-00010
• 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: 09/27/2017

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: 6040711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2011
• 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