MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REMB ELECTRIC RECIPROCATING SAW; ARTHROSCOPE

Model Number 6400037000

Device Problem Overheating of Device (1437)

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

Event Date 04/09/2022

Event Type  malfunction  

Event Description

The manufacturer service technician reported that the device overheated while it was being serviced at the user facility.There were no adverse consequences related to this event.

• Brand Name: REMB ELECTRIC RECIPROCATING SAW
• 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: 14193071
• MDR Text Key: 289967140
• Report Number: 3015967359-2022-00737
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613154938339
• UDI-Public: 07613154938339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112593
• 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: 04/25/2022

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: 6400037000
• Device Catalogue Number: 6400037000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Initial Date Manufacturer Received: 04/09/2022
• Initial Date FDA Received: 04/25/2022
• 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