MAUDE Adverse Event Report: STRYKER INSTRUMENTS MANDIBULAR OSTEOTOMY BLADE THIN

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2016

Event Type  malfunction  

Event Description

While performing surgery, a stryker saw blade and a stryker bur broke inside the pt's mouth.

• Brand Name: MANDIBULAR OSTEOTOMY BLADE THIN
• Type of Device: MANDIBULAR OSTEOTOMY BLADE THIN
• Manufacturer (Section D): STRYKER INSTRUMENTS; kalamazoo MI 49001
• MDR Report Key: 6186254
• MDR Text Key: 62913752
• Report Number: MW5066784
• Device Sequence Number: 0
• Product Code: HWE
• 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: 12/15/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR