MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SAGITTAL SAW ATTACHMENT; LARGE BONE POWERED SURGICAL SYSTEMS

Model Number 4100400000

Device Problem Material Disintegration (1177)

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

Event Date 07/20/2021

Event Type  malfunction  

Event Description

The sales representative reported the device is showing black sediment/metal shavings residing inside the device.There were no adverse consequences related to this event.

Event Description

The sales representative reported, during a surgical procedure, the device was showing black sediment/metal shavings residing inside the device.Black sediment/metal shavings from a device could potentially cause an infection.No clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a root cause could not be determined for the event.

• Brand Name: SAGITTAL SAW ATTACHMENT
• Type of Device: LARGE BONE POWERED SURGICAL SYSTEMS
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 12269341
• MDR Text Key: 264813664
• Report Number: 3015967359-2021-01722
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068323
• UDI-Public: 04546540068323
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

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: 4100400000
• Device Catalogue Number: 4100400000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1