MAUDE Adverse Event Report: SYNTHES TRAUMA : ORTHOSPIN MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-LNG; SOFTWARE FOR DIAGNOSIS/TREATMENT

Model Number 1100011-01

Device Problem Mechanical Problem (1384)

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

Event Date 01/17/2023

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.Patent identifier: (b)(6).Additional product code: ktt.Postal code-(b)(6).The product complaint details were sent to r&d for evaluation.Date investigation started ¿ 1/17/2023.Did we rule out customer issues? this issue was encountered by a customer.Therefore it is a customer issue.What actions did we take to identify the issue? the issue was identified during treatment with a system error indication.What actions did we take to resolve the issue? the issue was resolved by replacing the strut and the control unit.Was the complaint confirmed? the complaint was confirmed.The log shows that the encoder on motor 5 was unable to move.A subsequent test by product development team demonstrated that a manual mode movement in the software also would not work, and communication with the strut was lost.Upon further investigation it was discovered that the wiring between the control unit and the motor was damaged.It was determined that wire damage was the root cause of the complaint.Was the issue able to be replicated during investigation? yes, the issue was replicated during the investigation.The product development team was able to replicate the motor¿s inability to work.Document the results of the risk document review: a risk review was conducted of arena document and the risk is captured on with ¿encoder or its cables failure¿ and a harm of ¿device breakage - post-operatively ¿ moderate¿.The risk review identified that the risk is appropriately captured with an occurrence rate of 3 and a severity of 3.As part of depuy synthes quality process, all devices and software are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed.The root cause of the allegation is the damage on the device.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.

Event Description

It was reported that on (b)(6) 2023, that autostrut head unit was malfunctioning.Strut #5 malfunction.There was no surgical delay.The surgery was successfully completed.This report is for one (1) xframe autostrut(tm)hexapod strut-lng.This is report 2 of 2 for complaint (b)(4).

• Brand Name: MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-LNG
• Type of Device: SOFTWARE FOR DIAGNOSIS/TREATMENT
• Manufacturer (Section D): SYNTHES TRAUMA : ORTHOSPIN; 13 hayezira st.; yoqneam ; IS
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16528731
• MDR Text Key: 311136733
• Report Number: 3015781803-2023-00007
• Device Sequence Number: 1
• Product Code: OSN
• UDI-Device Identifier: 10886982338570
• UDI-Public: (01)10886982338570
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1100011-01
• Device Catalogue Number: 1100011-01
• Device Lot Number: 2109100045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KIT
• Patient Sex: Male