MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER IBUR 5.0MM COARSE DIAMOND ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number 8431-013-050DC

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/28/2023

Event Type  Injury  

Event Description

Burr broke while in use, all parts retrieved, no patient harm or delay in surgery.

• Brand Name: STRYKER IBUR 5.0MM COARSE DIAMOND ROUND
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS; portage MI 49002
• MDR Report Key: 16487348
• MDR Text Key: 310807802
• Report Number: MW5115433
• Device Sequence Number: 1
• Product Code: NLN
• 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: 02/28/2023

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: 8431-013-050DC
• Device Lot Number: 22224017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White