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	Device Slipped (1584); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.H11 additional narrative: e1: the initial reporter's complete address was not provided.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that the forehand grip and collar covering the anvil became separated was not confirmed.Therefore, an assignable root cause for the reported condition that the device fell apart/unattached was not determined.The assignable root cause of the remaining malfunctions found during service and repair was determined to be due to component failure from wear.
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was discovered that while broaching the femur using the impactor device it was observed that the device was damaged and the forehand grip became loose and began rotating.It was reported that the whole forehand grip and collar covering the anvil become separated.It was reported that there was a small delay to the surgical procedure however, the duration of the delay was not specified.A spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.

• 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 Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL ; 3035526892
• MDR Report Key: 22724869
• Report Number: 1045834-2025-00480
• Device Sequence Number: 8968126
• Product Code: GEY
• UDI-Device Identifier: 00845384018520
• UDI-Public: (01)00845384018520(20)12
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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: 07/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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