MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRODRILL STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL

Model Number 5100015250

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

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 13 events were reported for this quarter.Product return status 5 devices were received.1 device was not available for evaluation.7 device investigation types have not yet been determined.Additional information 13 devices were not labeled for single-use.13 devices were reprocessed or reused.

Event Description

This report summarizes 13 malfunction events in which the device reportedly overheated.10 events had no patient involvement; no patient impact.3 events had 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: 13 events were originally reported for this failure mode during the reporting quarter; however, 1 event was inadvertently excluded.14 reported events are included in this follow-up record.Product return status: 12 devices were received.2 devices were not available for evaluation.Additional information: 14 devices were not reprocessed or reused.

Event Description

This report summarizes 14 malfunction events in which the device reportedly overheated.10 events had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

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, h6, h10 14 events were previously reported during the reporting period; however, - 1 previously reported event in this report was included under mfr report # 3015967359-2022-01784.- 13 previously reported events are included in this follow-up record.Product return status 12 devices were received.1 device was not available for evaluation.

Event Description

This report summarizes 13 malfunction events in which the device reportedly overheated.- 10 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.

• Brand Name: MICRODRILL STRAIGHT ATTACHMENT
• Type of Device: 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: 15666689
• MDR Text Key: 302696287
• Report Number: 3015967359-2022-02126
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: 04546540380272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 13
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

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: 5100015250
• Device Catalogue Number: 5100015250
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 09/30/2022; 09/30/2022
• Supplement Dates FDA Received: 01/30/2023; 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1