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

Model Number 4100400000

Device Problem Material Disintegration (1177)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2020

Event Type  malfunction  

Event Description

The user facility reported the device emitted metal shavings during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Additional information: d9.

Event Description

The user facility reported the device emitted metal shavings during testing prior to 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: 9777349
• MDR Text Key: 181766662
• Report Number: 0001811755-2020-00605
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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: No Information
• Device Model Number: 4100400000
• Device Catalogue Number: 4100400000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1