MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN PKA INSERT TRIALS; PARTIAL KNEE INSTRUMENTS

Catalog Number UNK_OFL

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon complained during the pka that the plastic with our insert trials is brittle and not as strong as other companies.During pka¿s, he is noticing that during impaction of the trial, small chips of plastic are coming off the trial and having to be cleaned out of the patient¿s knee.

Manufacturer Narrative

An event regarding wear involving an unknown instrument mako trial was reported.The event was not confirmed.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: not performed as the device was not properly identified.Complaint history review: not performed as the device was not properly identified.Conclusions: it was reported that during impaction of the trial, small chips of plastic are coming off the trial and having to be cleaned out of the patient¿s knee.There was surgical delay of 5 minutes.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

The surgeon complained during the pka that the plastic with our insert trials is brittle and not as strong as other companies.During pka¿s, he is noticing that during impaction of the trial, small chips of plastic are coming off the trial and having to be cleaned out of the patient¿s knee.

• Brand Name: UNKNOWN PKA INSERT TRIALS
• Type of Device: PARTIAL KNEE INSTRUMENTS
• 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: 6661544
• MDR Text Key: 78376142
• Report Number: 3005985723-2017-00266
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/15/2017

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: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 09/15/2017
• 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