MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER MAKO BONE PIN; TRAY, SURGICAL INSTRUMENT

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/25/2019

Event Type  malfunction  

Event Description

During a bilateral total knee arthroplasty, the surgeon was putting in the tibia pin in the patient¿s hard bone when the pin broke on insertion in the posterior cortex of the tibia.

• Brand Name: STRYKER MAKO BONE PIN
• Type of Device: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 8396478
• MDR Text Key: 138112042
• Report Number: MW5084699
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 79