MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER ORTHOLOC EX-PIN 3 X 110; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2018

Event Type  malfunction  

Event Description

Tip of stryker ortholoc ex-pin 3 x 10 was broken when the surgeon handed it to surgical tech; device was in knee.The piece of the broken pin that was retained measured 1.5cm.X-ray confirmed piece in the knee and intentionally left so no further harm resulted.

• Brand Name: STRYKER ORTHOLOC EX-PIN 3 X 110
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 8042099
• MDR Text Key: 126508386
• Report Number: MW5081066
• Device Sequence Number: 0
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2018
• 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