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

Model Number 5100004000

Device Problem Device Remains Activated (1525)

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

Event Date 12/31/2020

Event Type  malfunction  

Event Description

This report summarizes 2 malfunction events in which the device had run-on.2 events had no patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 1 device was received.1 device investigation type has not yet been determined.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event in which the device had run-on.- 1 event had no patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h10 2 events were previously reported during the reporting period; however, - 1 previously reported event in this report should have been included under mfr report # 3015967359-2021-00527.- 1 previously reported events are included in this follow-up record.Product return status 1 device was received.

• Brand Name: STANDARD CABLE
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11215118
• MDR Text Key: 228489094
• Report Number: 0001811755-2021-00154
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540970275
• UDI-Public: 04546540970275
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5100004000
• Device Catalogue Number: 5100004000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1