MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP TPX CABLE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	7400-004-000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was overheating during testing.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.H3 other text : device was not returned.
Event or Problem Description
It was reported that the device was overheating during testing.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: TPX CABLE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• 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: 12857733
• Report Number: 3015967359-2021-02624
• Device Sequence Number: 4081053
• Product Code: ERL
• UDI-Device Identifier: 07613327483031
• UDI-Public: 07613327483031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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 Model Number: 7400-004-000
• Device Catalogue Number: 7400-004-000
• Device Lot Number: 1020233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown