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

Catalog Number 1100012-01

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2023

Event Type  malfunction  

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer.Review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported on an unknown date in 2023, that the surgeon was programming the autostrut head unit.Motor number 3 would not pass the initial test in the first screen in the software.The surgeon was advised to check the motor clip to make sure the motor was sitting in the strut appropriately, he confirmed it was.He then ran manual mode forward and backwards one time to see if the motor was turning the gear in the strut.It was confirmed the motor was lighting up green and it moved.He then tested again, but the strut did not pass.He replaced the short strut to see if the strut was the issue, but it still was not passing the initial test.The motor was removed and used the blue knob to be sure there was not too much tension on the strut.Confirmed there was not too much tension.The surgeon then used motor number 4 in strut number 3 during the test to see if it could pass, and it did.It was advised at that time to replace the head unit.The new head unit was applied and loading of the program passed and was successful.This report is for one (1) maxframe autostrut(tm) hexapod strut - short this is report 2 of 2 for complaint (b)(4).

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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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 STRUT - SHORT
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES TRAUMA : ORTHOSPIN; 13 hayezira st.; yoqneam 20667 20; IS 2066720
• Manufacturer Contact: oren cohen ; 13 hayezira st.; yoqneam 20667-20 ; IS 2066720
• MDR Report Key: 17573738
• MDR Text Key: 321472405
• Report Number: 3015781803-2023-00028
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982338594
• UDI-Public: (01)10886982338594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1100012-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KIT
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 131 KG