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

Catalog Number 5100015250

Device Problem Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2024

Event Type  malfunction  

Event Description

This report summarizes (b)(4) malfunction events in which the device or cutting accessory fractured.- (b)(4) events had no patient involvement; no patient impact.- (b)(4) event had insufficient information received.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events (b)(4) events were reported for this quarter.Product return status (b)(4) device was received.(b)(4) device investigation types have not yet been determined.Additional information (b)(4) devices were not labeled for single-use.(b)(4) devices were not reprocessed or reused.

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, h1, h6, h11 4 events were previously reported during the reporting quarter; however, - 1 previously reported event was included under mfr report # 3015967359-2024-00791 but should be included under this report.- 5 previously reported events are included in this follow-up record.Product return status 5 devices were received.

Event Description

This report summarizes 5 malfunction events in which the device or cutting accessory fractured.- 4 events had no patient involvement; no patient impact.- 1 event had insufficient information received.

• 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: 19113450
• MDR Text Key: 341021550
• Report Number: 3015967359-2024-00789
• 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: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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 Catalogue Number: 5100015250
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 03/31/2024
• Supplement Dates FDA Received: 04/26/2024
• 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