MAUDE Adverse Event Report: SYNTHES GMBH KINCISE SURGICAL AUTOMATED SYSTEM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	2000-00-001
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
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.
Event or Problem Description
It was reported that during a surgical procedure it was observed that the kincise surgical automated system device would activate and impact nine to ten times with one trigger pull.The trigger seems to get stuck.There was no report of a delay in the procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.
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 device was functionally / visually tested according to the diagnostic assessment the described failure by the customer was confirmed.The device was visually inspected as received from the customer.It was found that the device passed visual inspection.Investigation is based on assessment performed in the service center palm beach gardens during the initial assessment it was found that the device failed the following steps from the functional assessment: operation assessment during the assessment it was found that the bottom trigger was sticky, leading the device to keep impacting when the trigger was released.Due to this findings the device was forwarded to ttim.During the testing at tti it was confirmed that the device kept impacting after trigger was released due to sticky trigger.It was found that loctite was visible inside the retainer and on the trigger shaft indicating to much loctite was applied during assembly causing trigger issue.The most probable root cause can be traced to a manufacturing issue.Further investigation and assessment is covered under a nc in our quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.The conclusion of the dhr review is that the final products manufactured and released in the production processes relevant to the device in the current complaint met inspection requirements, certification test values, and acceptance criteria set by the applicable specification.Device history review: not relevant: review of the device history record(s) showed that there are no relevant issues during the manufacture of this product which would contribute to this complaint condition.

• Brand Name: KINCISE SURGICAL AUTOMATED SYSTEM
• 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: 24233612
• Report Number: 8030965-2026-01113
• Device Sequence Number: 13308847
• Product Code: HWE
• UDI-Device Identifier: 07612334268563
• UDI-Public: (01)07612334268563
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: 2000-00-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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