MAUDE Adverse Event Report: SYNTHES GMBH DOUBLE AIR HOSE, 3M, FOR AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC

Catalog Number	05.001.083
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H.10.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during an unspecified surgical procedure it was observed that while using the air pen drive device motor, the hose burst at the point where it connects to the handpiece.To provide a prompt solution, a competitor¿s motor was immediately given to the specialist, allowing the surgery to be successfully completed.It was reported that there was no delay in the procedure due to the event.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device was not returned for evaluation; however, a photo was received for review.Quality engineering evaluated the photo received and the failure described by the customer was confirmed.The received photo was reviewed and compared to a known good unit.It was found that the device failed visual inspection due to the wall coupling being detached from the inner and outer hose.Based on the provided photo it shows that the wall coupling detached from the inner and outer hose.At this stage of the investigation the cause for the found defect is improper handling by the user, based on the provided information.Furthermore, the investigation is only based on the provided photo, further assessment will be performed if the device is received.

• Brand Name: DOUBLE AIR HOSE, 3M, FOR 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 04436 ; SZ 04436 ; 9083863534
• MDR Report Key: 23585747
• Report Number: 8030965-2025-11556
• Device Sequence Number: 18467668
• Product Code: HBB
• UDI-Device Identifier: 07611819831520
• UDI-Public: (01)07611819831520
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 05.001.083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 11/28/2025; 12/15/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/01/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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: Male