MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRODRILL STRAIGHT ATTACHMENT; POWER TOOL ATTACHMENTS AND ACCESSORIES

Catalog Number	5100015250
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill overheated during a surgical procedure.The procedure was completed successfully without a clinically significant delay; the patient was reported to have received a burn to the tongue musculature which will require additional treatment.
Additional Manufacturer Narrative
Correction: d9; h3.The device was not returned for evaluation; therefore, a root cause could not be determined for the event.
Event or Problem Description
No new information.

• Brand Name: MICRODRILL STRAIGHT ATTACHMENT
• Common Device Name: POWER TOOL ATTACHMENTS AND ACCESSORIES
• 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: 23767167
• Report Number: 3015967359-2025-01715
• Device Sequence Number: 10593916
• Product Code: EIA
• UDI-Device Identifier: 04546540380272
• UDI-Public: (01)04546540380272(10)24249
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K032117
• 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,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5100015250
• Device Lot Number: 24249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown