MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MIS 13CM CURVED ATTACHMENT; DRILLING POWER TOOL ATTACHMENT, BASIC

Catalog Number	5407120950C
Medical Device Problem Codes	Fracture (1260); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Full udi is unknown as device is unknown.
Event or Problem Description
During a procedure, the device was overheating, and the bur broke.The delay was minor, and the procedure was completed with no adverse consequences.
Additional Manufacturer Narrative
Updated fields: d4, d9, g4, h2, h3, h4.
Event or Problem Description
No new information.

• Brand Name: MIS 13CM CURVED ATTACHMENT
• Common Device Name: DRILLING POWER TOOL ATTACHMENT, BASIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer Contact: kelsey barla ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 21401772
• Report Number: 3015967359-2025-00434
• Device Sequence Number: 9576330
• Product Code: HBE
• UDI-Device Identifier: 07613327096491
• UDI-Public: (01)07613327096491
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: Health Professional
• Device Catalogue Number: 5407120950C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2022
• 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