MAUDE Adverse Event Report: STRYKER CORP. STRYKER CHECKPOINT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 111653

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/19/2021

Event Type  malfunction  

Event Description

Stryker checkpoint broke off while the surgeon was attempting to remove from the patient's pelvic bone.The head of the check point was still attached to sutures but the point itself stayed in the pt's pelvic bone.Confirmation xray was taken showing the point still in the bone not protruding out of the bone.Fda safety report id# (b)(4).

• Brand Name: STRYKER CHECKPOINT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 11702086
• MDR Text Key: 246974921
• Report Number: MW5100917
• Device Sequence Number: 1
• Product Code: OLO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 111653
• Device Catalogue Number: 111653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• 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: 84 YR
• Patient Weight: 108