MAUDE Adverse Event Report: SYNTHES GMBH ELECTRIC PEN DRIVE 60,000 RPM; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	05.001.010
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H10 additional narrative: investigation summary: the actual device was returned for evaluation.A visual and functional assessment was performed on the device.The following steps failed: check general function with test hand switch.During the service evaluation the following failures were identified: functional: unintended activation/motion.Conclusion: failure reported is confirmed.The assignable root cause was determined to be due to component failure from wear.
Event or Problem Description
It was reported that during service and evaluation, it was determined that the electric pen drive device experienced unintended activation/motion.It was noted in the service order that the device was faulty during reprocessing.This event did not occur during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.

• Brand Name: ELECTRIC PEN DRIVE 60,000 RPM
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; eimattstrasse 3; oberdorf 04436 ; SZ 04436 ; 9083863534
• MDR Report Key: 25779965
• Report Number: 8030965-2026-07024
• Device Sequence Number: 10721845
• Product Code: ERL
• UDI-Device Identifier: 07611819167711
• UDI-Public: (01)07611819167711
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

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: 05.001.010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2017
• 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