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

Model Number 5100015272

Device Problem Overheating of Device (1437)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2019

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: 2 events were reported for this quarter.Product return status: 2 device investigation types have 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 2 malfunction events in which the device reportedly overheated.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.Supplemental rationale corrected data: b5, h10 2 events were previously reported during the reporting quarter; however:  - 1 event was reported in error.- 1 previously reported event is included in this follow-up record.Product return status 1 device was received.

Event Description

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

• Brand Name: MD SERIES LONG ANGLED ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9637286
• MDR Text Key: 177613667
• Report Number: 0001811755-2020-00322
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540391810
• UDI-Public: 04546540391810
• 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: 01/28/2021

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: 5100015272
• Device Catalogue Number: 5100015272
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1