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

Model Number 1100010-01

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2023

Event Type  Injury  

Event Description

It was reported that the patient stated he was sliding down the stairs to get to the main floor and strut number 5 had broken.The patient's mother stated that dontorious bangs the strut on every step on the way down.The mother zip-tied the strut to the ring, and it was broken for a total of two days.The surgeon checked the strut lengths of all six struts, and the program had kept them within 1-2mm of the planned robotic schedule.Strut number 5, even though it had broken two days prior to the strut change, was also within the 1-2mm difference, and the surgeon felt it had no negative impact on patient care.Strut 5 was a medium strut, and it broke through the shoulder bolt knuckle connection.The product is available for return.The scheduled strut change was successful, and no harm to the patient was observed.Strut 5 was a scheduled strut change on this date, and it was replaced with a large auto strut.This also needed a new shoulder bolt because of the strut failure, so they will have both the strut and the shoulder bolt available for return.This report is for one (1) maxframe autostrut(tm)hexapod strut-med this is report 1 of 1 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.H10 additional narrative: d2b: additional product code: ktt d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.H3, h6: 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.

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.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to westchester team team which conducted a visual inspection of the returned device.The issue was identified during device testing, and it was solved by replacing the strut.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for maxframe autostrut(tm)hexapod strut-med there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MED
• Type of Device: SOFTWARE FOR DIAGNOSIS/TREATMENT
• 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: 17270000
• MDR Text Key: 318559948
• Report Number: 3015781803-2023-00023
• Device Sequence Number: 1
• Product Code: OSN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1100010-01
• Device Catalogue Number: 1100010-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MAXFRAME(TM) SHOULDER BOLT FOR 8MM RINGS.
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 160 KG