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

Model Number 4100400000

Device Problem Overheating of Device (1437)

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

Event Date 02/09/2021

Event Type  malfunction  

Event Description

The device overheated during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.

• Brand Name: SAGITTAL SAW ATTACHMENT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 11424115
• MDR Text Key: 235026884
• Report Number: 3015967359-2021-00062
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068323
• UDI-Public: 04546540068323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1