MAUDE Adverse Event Report: STRYKER CORPORATION; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7207000000

Device Problems Failure to Cut (2587); Defective Device (2588)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Stryker sternal saw would not work when attempting to saw through sternum prior to open heart surgery.Had to retrieve new sternal saw to complete task.What: stryker sternal saw malfunctioned during incision time in mor.Why: possibly due to age or condition of equipment which has been in use since 2015.Batteries were checked and found to be working appropriately.How: continue power monitoring (pm) of power equipment every 6 months, although this past year the contract was changed from stryker to agility so third party repairs are being used.Many of our batteries are also very old and need to be replaced.Outcome; as determined by surgeon.Saw was sent out for repair to agility.

• Brand Name: NA
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 16731487
• MDR Text Key: 313217353
• Report Number: 16731487
• Device Sequence Number: 1
• Product Code: HWE
• 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: 04/07/2023

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: Other
• Device Model Number: 7207000000
• Device Catalogue Number: 7207000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Male
• Patient Race: White