MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKER DRILL BIT; BIT, DRILL

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/03/2023

Event Type  Injury  

Event Description

Tip of stryker reamer broke off into patient.Attempts were made to retrieve tip, but eventually tip was retrieved in suction filter of neptune.Filter was opened and piece was recovered.Piece was saved by or(operating room) charge and management was made aware.Piece was saved and placed in or(operating room) managers office for follow up with risk management.

• Brand Name: STRYKER DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 16399462
• MDR Text Key: 309914244
• Report Number: MW5115035
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White