MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SAGITTAL SAW ATTACHMENT; ARTHROSCOPE

Model Number 4100400000

Device Problems Material Disintegration (1177); Fracture (1260)

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

Event Date 03/29/2021

Event Type  malfunction  

Event Description

The user facility reported that the device had pieces coming out after a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Event Description

The user facility reported that the device had pieces coming out after a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: SAGITTAL SAW ATTACHMENT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11608504
• MDR Text Key: 243826893
• Report Number: 3015967359-2021-00333
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068323
• UDI-Public: 04546540068323
• Combination Product (y/n): N
• PMA/PMN Number: K943323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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: Health Professional
• Device Model Number: 4100400000
• Device Catalogue Number: 4100400000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1