MAUDE Adverse Event Report: THE ANSPACH EFFORT LLC HIGH SPEED ELEC G1 HANDPIECE AIR COOLED; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	EG1A
Medical Device Problem Codes	Energy Output Problem (1431); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: a visual and functional assessment was performed: the following steps failed: visual assessment break out box motor assessment temperature verification temperature verification during service/repair the following was observed : [pre-internal comment: ng, positioning line (gripping part line) fading, red dot on connector missing, hose damaged, resistance value ng, overheating] during the service evaluation the following failures were identified: visual : cosmetic damage.Visual : cord damaged.Functional : moving parts do not move smoothly.Functional : heat.Conclusion: ¿ failure reported is not confirmed.¿ root cause: component wear.
Event or Problem Description
It was reported that during service and evaluation, it was determined that the handpiece device had heat.It was noted in the service order that the device speed would not rise.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.

• Brand Name: HIGH SPEED ELEC G1 HANDPIECE AIR COOLED
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): THE ANSPACH EFFORT LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: elba bello ; 4500 riverside drive; palm beach gardens, FL 33410 ; 9083863534
• MDR Report Key: 23870310
• Report Number: 1045834-2025-00653
• Device Sequence Number: 4619586
• Product Code: ERL
• UDI-Device Identifier: 00845384017134
• UDI-Public: (01)00845384017134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: Health Professional
• Device Catalogue Number: EG1A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown