MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 7CM STRAIGHT ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407120450

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2024

Event Type  malfunction  

Event Description

This report summarizes 107 malfunction events in which the device reportedly overheated.- (b)(4) events had no patient involvement; no patient impact.- (b)(4) events had patient involvement; no patient impact.- (b)(4) events had insufficient information received.- (b)(4) 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.Reported events: (b)(4) events were reported for this quarter.Product return status: (b)(4) devices were evaluated based on historical data analysis.(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.

• Brand Name: ELITE 7CM STRAIGHT ATTACHMENT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: 19113408
• MDR Text Key: 341002775
• Report Number: 3015967359-2024-00813
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 07613327096545
• UDI-Public: 07613327096545
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 107
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2024

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: 5407120450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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