MAUDE Adverse Event Report: SYNTHES GMBH AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC

Catalog Number	05.001.080
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
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.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Event or Problem Description
It was reported that during an unspecified surgical procedure, the handpiece device remained activated even after the trigger was released.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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.H11 additional narrative: the received video was reviewed.The described failure by the customer was confirmed the received video was reviewed and compered to a known good unit.It was found that the device passed visual inspection.Based on the provided video it shows that, the device wouldn¿t stop directly when the handle switch was released.At this stage of the investigation the root cause for the found defect cannot be fully determined, based on the provided information.Furthermore, the investigation is only based on the provided video, further assessment will be performed if the device is received.As part of synthes quality process devices are serviced / inspected, and released to approved specifications.The instructions for use states the following regarding the reported issue that was observed by the user: check instruments and cuttings tools for correct adjustment and functioning prior to every use.In case that any damage or wear is visible, do not use it anymore and send it to the synthes service center.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review = > due to available service history, dhr review only covers the related service records.Service history record review result is not relevant to the current complaint.

• Brand Name: AIR PEN DRIVE
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 9083863534
• MDR Report Key: 24664654
• Report Number: 8030965-2026-02739
• Device Sequence Number: 13072439
• Product Code: HBB
• UDI-Device Identifier: 07611819830899
• UDI-Public: (01)07611819830899
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K093361
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 05.001.080
• Device Lot Number: 4910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2020
• 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: Female