MAUDE Adverse Event Report: MAKO SURGICAL CORP.; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 213524

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Stryker bone pin broke and let a small remnant of the pin in the tibia during a robotic-assisted total knee replacement.The metallic fragment was intentionally left inside the tibia.Per surgeon, no adverse reaction is expected.

• Brand Name: NA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• MDR Report Key: 12770488
• MDR Text Key: 280459137
• Report Number: 12770488
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 213524
• Device Catalogue Number: 213524
• Device Lot Number: 48221119
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male