MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE¿ AUTOMATED SURGICAL IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	1000-00-101
Medical Device Problem Codes	Unintended System Motion (1430); Physical Resistance/Sticking (4012); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the impactor device was had a sticky trigger and unintended activation.It was noted in the service order that the device was misfiring during surgery.There were no reports of 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 device was functionally / visually tested.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 the assessment performed by the complaint technical investigator.The kincise surgical impactor was visually and functionally assessed, and the impactor operated.However, the trigger was observed to be difficult to press/depress, resulting in unintended operation, consistent with lack of lubricant ¿ improper maintenance.The kincise surgical impactor trigger was lubricated per the instructions for use, and the trigger was able to press/depress without difficulty.The most relevant root causes are linked to improper maintenance.As part of anspach quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use states the following regarding the reported issue that was observed by the user or customer: lubricate the surgical impactor following the completion of every cleaning and disinfection and prior to sterilization.Follow the lubricant manufacturer¿s instructions for use (i.E.Concentration/dilution and shelf life).Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: KINCISE¿ AUTOMATED SURGICAL IMPACTOR
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC
• Manufacturer Contact: elba bello ; 4500 riverside drive; palm beach gardens, FL 33410 ; 9083863534
• MDR Report Key: 24393071
• Report Number: 1045834-2026-00048
• Device Sequence Number: 13326382
• Product Code: GEY
• UDI-Device Identifier: 00845384018520
• UDI-Public: (01)00845384018520(20)12
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 1000-00-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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