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

Catalog Number 5407120452

Device Problem Flaked (1246)

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

Event Date 12/31/2023

Event Type  malfunction  

Event Description

This report summarizes 55 malfunction events in which the device had paint chips missing.- 55 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.Reported events 55 events were reported for this quarter.Product return status 55 devices were evaluated in the field.Additional information 55 devices were not labeled for single-use.55 devices were not reprocessed or reused.

Event Description

This report summarizes 57 malfunction events in which the device had paint chips missing.57 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: 55 events were originally reported for this failure mode during the reporting quarter; however, 2 events were inadvertently excluded.57 reported events are included in this follow-up record.Product return status: 57 devices were evaluated in the field.Additional information: 57 devices were not labeled for single-use.57 devices were not reprocessed or reused.

• Brand Name: ELITE 7CM 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: 18518216
• MDR Text Key: 332929732
• Report Number: 3015967359-2024-00077
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 07613327096552
• UDI-Public: 07613327096552
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 57
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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: 5407120452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 12/31/2023
• Supplement Dates FDA Received: 01/22/2024
• 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