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

Catalog Number	5407120472
Medical Device Problem Codes	Flaked (1246); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during service by the manufacture that the color band was flaking and the device was overheating.There is no patient involvement or adverse consequences.

• Brand Name: ELITE 12CM ANGLED ATTACHMENT
• Common Device Name: 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22872859
• Report Number: 3015967359-2025-01402
• Device Sequence Number: 5689738
• Product Code: HBE
• UDI-Device Identifier: 07613327096576
• UDI-Public: (01)07613327096576
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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
• Operator of Device: Other
• Device Catalogue Number: 5407120472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown