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

Model Number 1100010-01

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Additional pro-code: osn.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 that on an unknown date, the medium auto-strut broke at proximal ball joint at of end of treatment.The strut broke a few days before planned removal.This complaint involves one device.This report is for one 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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 and sent to r&d for evaluation.The r&d team conducted a visual inspection of the returned device.Visual analysis of the returned sample was performed on maxframe autostrut(tm)hexapod strut-med.Did we identify customer misuse? yes.The surgeon was contacted and interviewed by depuy synthes r&d.The surgeon confirmed that he did not use the 10 nm torque wrench when tightening the clevises and construct.What actions did we take to identify the issue? visual observations revealed surface coating of clevis was mechanically stripped off and the flats were deformed, indicating higher levels of torque applied beyond intended use to the device.Checked the material coc and confirmed the proper material was used.Mechanical inspection of break area indicated parts in specification.Sent device to metallurgy lab for failure assessment and identification.The conclusions of the report are as follows: ¿the maxframe autostrut locking joint component was loaded beyond the material limit in bending caused by impingement with an unknown component during use resulting in a high stress, low cycle fatigue fracture initiation within the distal region of the threaded diameter.Evidence of impingement was observed between the locking joint component and the body of the autostrut further confirms the joint was stressed significantly during use.No evidence of material or manufacturing defects was observed.¿ o using a new strut and the crescent wrench instrument, we recreated the tightening process without the torque wrench to create the visual wear that was consistent with the complaint device.Tightening torque was estimated to be at least 15nm or more.Was the complaint confirmed? yes, we received the clevis joint split in half and broken which was consistent with the description.Was the issue able to be replicated during investigation? no.Investigation only of returned parts, no replications.Is this complaint included in the risk management file (what number and category)? yes, line #108 in qsd-0169 g2 risk analysis (fmea) rev i.Device functionality is damaged ¿ device breakage.Is this complaint within the occurrence rate and is the harm consistent with the complaint? yes.Document the results of the orthospin¿s risk document review: there was no patient harm and within occurrence rate.The occurrence rate is listed as a 2, meaning there is remote probability - ¿unlikely, but possible to occur in life of an item¿.The life of the item indicates useful life on the patient, as this is single use.As for patient harm, there is no patient harm.The risk document lists severity as a 3, meaning ¿results in injury or impairment requiring professional medical intervention¿.The patient was post alignment, at the end of their consolidation phase and at the point of frame removal, therefore there was no harm to the patient.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the maxframe autostrut(tm)hexapod strut-med.There is no indication that a design or manufacturing issue has caused the complaint condition.The root cause has been traced to user error.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: 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: 16328697
• MDR Text Key: 309134311
• Report Number: 3015781803-2023-00004
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982338587
• UDI-Public: (01)10886982338587
• 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,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• 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: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female