MAUDE Adverse Event Report: SYNTHES TRAUMA : ORTHOSPIN MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KIT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	1100007-01
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024 the autostrut contained exposed wires on one of the motors.There was no involvement of any operation and patient.There was no patient consequences.No other information was provided.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d9.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Note: the complaint device was evaluated and investigated by the manufacturing site.Visual inspection of the returned device revealed that the cable was damaged while in the field.The customer attempted to connect to the device but was unable to because of the device damage.The issue was identified during product use.The issue was resolved by replacing the control unit without patient involvement of harm.Therefore, the complaint was confirmed.The overall complaint was confirmed as the observed condition of the maxframe autostrut(tm)hexapod crlsys kit would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: per franchise complaint product investigation procedure 100673626 is for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KIT
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES TRAUMA : ORTHOSPIN; 13 hayezira st.; yoqneam 20667 20; IS 2066720
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20609408
• Report Number: 3015781803-2024-00009
• Device Sequence Number: 20868944
• Product Code: KTT
• UDI-Device Identifier: 10886982338600
• UDI-Public: (01)10886982338600
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup,Followup
• Report Date (Section B): 11/04/2024

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: 1100007-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 10/06/2025; 10/10/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 10/07/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown