MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 12CM ANGLED ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407120472

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2024

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: (b)(4) events were reported for this quarter.Product return status: (b)(4) devices were received.(b)(4) devices were not available for evaluation.(b)(4) devices were evaluated based on historical data analysis.(b)(4) device investigation type has not yet been determined.Additional information (b)(4) devices were not labeled for single-use.(b)(4) devices were not reprocessed or reused.

Event Description

This report summarizes (b)(4) 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.

Event Description

This report summarizes 188 malfunction events in which the device reportedly overheated.165 events had no patient involvement; no patient impact.23 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 corrected data: h6, h11.188 previously reported events are included in this follow-up record.Product return status 7 devices were received.2 devices were not available for evaluation.179 devices were evaluated based on historical data analysis.

• Brand Name: ELITE 12CM ANGLED 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: 19113412
• MDR Text Key: 341002935
• Report Number: 3015967359-2024-00822
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 188
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2024

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: 5407120472
• 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: 07/27/2024
• 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