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 Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-surgery testing it was observed that the trigger of the impactor device was stuck.This event did not occur during surgery.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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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 ben 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.A review of the device history was performed and no non-conformances were detected related to the reported condition.
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: correction d3, g1; please note that the legal manufacturer facility name and address have been updated.
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 not 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: uut impacts with the top trigger, the bottom trigger, and the reverse button: fail the device was visually and functionally assessed and it was found that the device was unable to produce impacts.Due to this findings the device was forwarded to ttim.During the testing at tti it was found that the handpiece was unable to produce impacts due to faulty battery foot.The faulty battery foot was exchanged with a known good battery foot and the handpiece was running according specification.A clear root cause cannot be determined for the for the faulty battery foot.As part of anspach quality process all devices are manufactured, inspected, and released to approved specifications.The ifu states the following regarding the reported issue that was observed by the user: if the surgical impactor does not perform an impact, reference the troubleshooting section of these instructions for use.If the surgical impactor continues to not operate properly, contact your sales representative for disposal and replacement.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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 FL 4436 ; SZ 4436
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf, FL 4436 ; SZ 4436 ; 9083863534
• MDR Report Key: 23003461
• Report Number: 1045834-2025-00529
• Device Sequence Number: 21041126
• Product Code: HWE
• UDI-Device Identifier: 07612334268563
• UDI-Public: (01)07612334268563
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup,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: 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: 08/21/2025
• Supplement Date Received by Manufacturer: 10/10/2025; 02/02/2026; 03/06/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/15/2025; 02/02/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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