MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS

Model Number 210080

Device Problems Crack (1135); Material Frayed (1262); Sharp Edges (4013)

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

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available.

Event Description

Stryker mako leg holders. Numerous pieces have exposed fibers, two pieces have stress fractures at the point where the metal fitting is inserted. Report of "someone getting stuck" by an exposed fiber. Case type: tka. Patient was under anesthesia. Update : how many surgeries were involved with the reported issue? approximately 300 procedures to get to this point. All the reported devices that are included in this complaint were for one or many surgeries? many ¿ spd called us concerned about exposed fibers and cracks. Have you reported each incident separately that has the issues you have mentioned in this complaint? (if no, please submit a complaint for each issue. ) no ¿ multiple leg holders are exhibiting wear. The items listed in the per either have exposed fibers or cracks. Please confirm if there was a patient that was ¿stuck¿ by the exposed carbon fiber? not a patient ¿ a staff member.

• Brand Name: BOOT ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9577450
• MDR Text Key: 178581182
• Report Number: 3005985723-2020-00018
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/10/2020 Patient Sequence Number: 1