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

Catalog Number	05.001.080
Medical Device Problem Codes	Break (1069); Unintended System Motion (1430); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
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.H10 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 the lock on the air pen drive device was not blocking and when switching from function it stays attached and locks the engine in operation directly.It was reported that the situation was resolved by managing to pass the blockade in different functions, thus achieving that it will remain in command of the hand.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: additional information b5: event description update: it is reported that during the procedure the safety lock on the air pen motor handpiece is not blocking and when changing functions it gets stuck and blocks, leaving the motor running directly.This situation was resolved by managing to overcome the blockage in different functions, thus achieving that it will remain in control of the hand.Due to this novelty there was no discomfort on the part of the specialist but he did request that this handpiece be reviewed; the surgery was completed successfully, without affectations to the patient and without alterations in surgical times.
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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the air pen drive device had was leaking air, had insufficient/low power, unintended activation/motion, and component damage.It was further determined that the device failed pretest for general condition, check for unintended motion, check general function with apd hand switch, check power with power test bench, check speed with tachometer, check for internal leak tightness, and check for external leak tightness.Therefore, the reported condition of unintended motion was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.

• Brand Name: AIR PEN DRIVE
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 21962645
• Report Number: 8030965-2025-04545
• Device Sequence Number: 7265772
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 05.001.080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 05/12/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/06/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2015
• 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