MAUDE Adverse Event Report: MAKO SURGICAL CORP. / STRYKER CORP. STRYKER MAKO CHECKPOINT

Model Number 111653

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/21/2018

Event Type  Injury  

Event Description

Patient in surgery for a right total hip replacement using stryker mako robotic arm interactive orthopedic system.Immediately upon removal of the pelvic checkpoint, it was noted that the tip of the checkpoint was retained in the superior acetabular bone stock.The area was exposed and the retained tip was nit visible above the cortical bone.The decision was made to leave the retained checkpoint tip rather than compromise the superior acetabular bone stock to search for the tip.Patient and his family were notified with this disclosure documented in the ehr.

• Brand Name: STRYKER MAKO CHECKPOINT
• Type of Device: CHECKPOINT
• Manufacturer (Section D): MAKO SURGICAL CORP. / STRYKER CORP.
• MDR Report Key: 8206306
• MDR Text Key: 131934268
• Report Number: MW5082684
• Device Sequence Number: 0
• Product Code: OLO
• Combination Product (y/n): N
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2023
• Device Model Number: 111653
• Device Lot Number: W58827
• Was Device Available for Evaluation?: Yes
• 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: 56 YR
• Patient Weight: 103