MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STANDARD CABLE; UNIT, OPERATIVE DENTAL

Model Number	5100004000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 4 events were reported for this quarter.Product return status: 4 device investigation types have not yet been determined.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly overheated.- 1 event had no patient involvement; no patient impact.- 3 events had insufficient information received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 4 events were previously reported during the reporting quarter; however, - 1 event was reported in error.3 previously reported events are included in this follow-up record.Product return status: 2 devices were received.1 device was not available for evaluation.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.

• Brand Name: STANDARD CABLE
• Common Device Name: UNIT, 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: 15102159
• Report Number: 3015967359-2022-01463
• Device Sequence Number: 4149550
• Product Code: EIA
• UDI-Device Identifier: 04546540970275
• UDI-Public: 04546540970275
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 5100004000
• Device Catalogue Number: 5100004000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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