MAUDE Adverse Event Report: SYNTHES GMBH COMPACT AIR DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	511.701
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the compact air drive device trigger was sticky.It was reported in the service order that the device safety and reverse mode did not function.It was unknown when the event occurred.There were no reports of delays to a surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2025.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: a visual and functional assessment was performed on the device the following steps failed: check for sticky trigger check fwd & rev mode function check power with power test bench.During the service evaluation the following failures were identified: functional : sticky trigger functional : insufficient/low power.Conclusion: failure reported is confirmed.
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: a visual and functional assessment was performed on the device.The following steps failed: check for sticky trigger.Check fwd & rev mode function.Check power with power test bench.Check for air leak.During the service evaluation the following failures were identified: functional : sticky trigger.Functional : insufficient/low power.Functional : leak - air.Conclusion: - failure reported is confirmed.
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: a visual and functional assessment was performed on the device.The following steps failed: check for sticky trigger check fwd & rev mode function check power with power test bench during the service evaluation the following failures were identified: functional : sticky trigger functional : insufficient/low power conclusion: ¿ failure reported is confirmed.

• Brand Name: COMPACT AIR DRIVE II
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 24203517
• Report Number: 8030965-2026-00999
• Device Sequence Number: 5558068
• Product Code: HWE
• UDI-Device Identifier: 07611819085268
• UDI-Public: (01)07611819085268(20)15
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 01/28/2026

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: 511.701
• Device Lot Number: 40030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 03/05/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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