MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP TPS UNIDIRECTIONAL FOOTSWITCH; OPERATIVE DENTAL

Model Number	5100007000
Medical Device Problem Codes	Failure to Power Up (1476); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the device was non-functional during a procedure.The user facility made the clinical decision to not proceed with the second part of the procedure, a mastoidectomy.Attempts are being made to obtain additional information from the user facility.
Additional Manufacturer Narrative
Correction: d9, h3.Additional info h6.H3 other text : device not returned by customer.
Event or Problem Description
The user facility reported that the device was non-functional during a procedure.The user facility made the clinical decision to not proceed with the second part of the procedure, a mastoidectomy.

• Brand Name: TPS UNIDIRECTIONAL FOOTSWITCH
• Common Device Name: OPERATIVE DENTAL
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17175294
• Report Number: 3015967359-2023-01339
• Device Sequence Number: 14341373
• Product Code: EIA
• UDI-Device Identifier: 04546540401724
• UDI-Public: 04546540401724
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5100007000
• Device Catalogue Number: 5100007000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown