MAUDE Adverse Event Report: SS WHITE BURS INC. BURR; BURR, ORTHOPEDIC

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

"it was reported that during testing of a stryker core impaction drill by the customer prior to a procedure, it was noted there was a broken bur inside the handpiece.It was also reported that there was no patient involvement, adverse consequences, medical intervention or delays as a result of this event" stryker instruments conducted a complaint investigation as a result of this information (stryker reference (b)(4)).However, through the course of the investigation, it was confirmed that the broken bur was not a stryker bur.The manufacturer of the bur, ss white burs inc.Has been notified of this event on (b)(6) 2012.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BURR
• Type of Device: BURR, ORTHOPEDIC
• Manufacturer (Section D): SS WHITE BURS INC.
• MDR Report Key: 17532216
• MDR Text Key: 321104300
• Report Number: MW5139124
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1