MAUDE Adverse Event Report: SYNTHES GMBH MAXFRAME AUTOSTRUT (TM) AUTOMATED HEXAPOD CTRL SYS KIT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	03.314.000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a maxframe autostrut head unit was being uploaded with a replan.During the testing process of the individual motors, strut 1 would not function properly.The motor on strut 1 would turn but it would keep turning clockwise for about 2-3 seconds.The rest of the struts on this head unit would turn clockwise, then counterclockwise correctly.Then would give the appropriate ¿check mark¿ in the software program.Strut 1 however, kept doing as previously mentioned and did not give the check mark.A new head unit was installed and uploaded with the replan for the patient.All motors functioned properly and the check marks appeared as they were supposed to prior to uploading the program.The program was then uploaded and started.Post op, they replanned with the existing head unit.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6: lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.The photo investigation revealed that maxframe autostrut(tm)hexapod ctrl kit, the provided evidence was not sufficient to confirm the reported event of does not function.Functionality issues cannot be evaluated through a photo investigation.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the wire exiting motor 1 was significantly kinked.No perforations to the outer jacket.Motors 1-3 were tested.Motor 1 ran for approximately 5 seconds competing almost 2 revolutions.Motors 2 and 3 operated as intended.When i moved the wire to the opposite side of the kink, and retested, the motor worked as intended.This shows there is a loose or frayed wire inside, causing an issue with the encoder circuit.The software worked as intended to protect the patient.After 5 seconds, the motor shots off as intended.The observed condition of the device is consistent with a component failure that was caused by continuous bending of the wires a dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the maxframe autostrut(tm)hexapod ctrl kit would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The drawings reflecting the current and manufactured revisions were reviewed.

• Brand Name: MAXFRAME AUTOSTRUT (TM) AUTOMATED HEXAPOD CTRL SYS KIT
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24592815
• Report Number: 8030965-2026-02508
• Device Sequence Number: 10114982
• Product Code: KTT
• UDI-Device Identifier: 10886982346872
• UDI-Public: (01)10886982346872
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 03.314.000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown