MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL

Model Number 5100015270

Device Problem Overheating of Device (1437)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 3 events were reported for this quarter.Product return status: 3 device investigation types have not yet been determined.3 devices were not labeled for single-use.3 devices were not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.2 events had no patient involvement; no patient impact.1 event had no known impact or consequences to the patient.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.3 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.Supplemental rationale corrected data: b5, h10 3 previously reported events are included in this follow-up record.Product return status 2 devices were received.1 device investigation type has not yet been determined.Event confirmation status 2 reported events were not confirmed.Evaluation results 1 device was found to be affected by wear damage.1 device was found to be affected by corroded bearings.

Event Description

This report summarizes 3 malfunction events in which the device reportedly overheated.3 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.Supplemental rationale corrected data: b5, h10 3 previously reported events are included in this follow-up record.Product return status 3 devices were received.Event confirmation status 3 reported events were not confirmed.Evaluation results 2 devices were found to be affected by corroded bearing.1 device was found to be affected by wear damage.

• Brand Name: MD SERIES LONG STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9998463
• MDR Text Key: 190385485
• Report Number: 0001811755-2020-01193
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380289
• UDI-Public: 04546540380289
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

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: No Information
• Device Model Number: 5100015270
• Device Catalogue Number: 5100015270
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 03/31/2020; 03/31/2020
• Supplement Dates FDA Received: 07/30/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1