MAUDE Adverse Event Report: STRYKER CORPORATION; BLADE, SAW, SURGICAL, CARDIOVASCULAR

Model Number 0298097101

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

Narrative from staff: starting coronary artery bypass graft, while sawing sternum the blade broke in half.

• Brand Name: NA
• Type of Device: BLADE, SAW, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 15216601
• MDR Text Key: 297791832
• Report Number: 15216601
• Device Sequence Number: 1
• Product Code: DWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0298097101
• Device Catalogue Number: 0298-097-101
• Device Lot Number: 21354027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Female
• Patient Weight: 82 KG