MAUDE Adverse Event Report: STRYKER NAVIGATION STRYKER ORTHOLOCK EX-PIN 3.310; TRACKER PIN

Model Number STRYKER ORTHOLOCK EX-PIN 3.110

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2017

Event Type  malfunction  

Event Description

Two stryker ortholock ex-pin 3x110 tracker pin tips broke off during removal, and were unable to be removed without risk to the pt.

• Brand Name: STRYKER ORTHOLOCK EX-PIN 3.310
• Type of Device: TRACKER PIN
• Manufacturer (Section D): STRYKER NAVIGATION; 4100 e. milham ave; kalamazoo ME 49001
• MDR Report Key: 6409129
• MDR Text Key: 70252409
• Report Number: MW5068467
• Device Sequence Number: 1
• Product Code: HAW
• 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: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: STRYKER ORTHOLOCK EX-PIN 3.110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR