MAUDE Adverse Event Report: PROVISION STRYKER; BURR, ORTHOPEDIC

Model Number 1607-002-107

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

Intraoperative, physician stated that the tip of a stryker 1.6mm taper side cutting carbide bur (ref# (b)(4), lot # 21109017, exp 04/01/2026) broke off in the patient's bone during a maxillofacial surgery.The tip of the bur was retrieved out of the bone by physician.

• Brand Name: STRYKER
• Type of Device: BURR, ORTHOPEDIC
• Manufacturer (Section D): PROVISION; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12561558
• MDR Text Key: 274316466
• Report Number: 12561558
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1607-002-107
• Device Catalogue Number: 1607-002-107
• Device Lot Number: 21109017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA