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

Model Number 210080

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Reported issue - surgeon brought to attention that the leg holder had chipped and had an exposed sharp edge. Product inspection - visual inspection confirmed leg holder is chipped. Product history review ¿ a review of the product history records indicates that 20 devices were manufactured under catalog #210080 lot no 201843101633, and all were accepted into final stock on 02/03/2020. There were no non-conformities identified during inspection. Complaint history review ¿ a review of complaints related to p/n (b)(4), lot 201843101633 shows no additional complaint(s) related to the failure in this investigation. Nc/capa history review - a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event. Conclusion ¿ the event was confirmed. Per (b)(4), preventive maintenance is where an action occurs that identifies device deterioration which may compromise function. Under pm conditions no patient was involved, and no actual or potential patient harm existed for the alleged event. No additional investigation or specific actions are required.

Event Description

Surgeon brought to attention that the leg holder had chipped and had an exposed sharp edge. Case type: tka.

• 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: 9765805
• MDR Text Key: 181574922
• Report Number: 3005985723-2020-00118
• Device Sequence Number: 1
• Product Code: OLO
• 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

• 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: 02/27/2020
• 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: 201843101633
• 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?: Yes
• 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: 02/27/2020 Patient Sequence Number: 1