MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DUAL-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 179722000S

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2024

Event Type  Injury  

Event Description

Device report from synthes reports an event in united kingdom as follows: it was reported on january 15, 2024, that this patient had a scoliosis correction approximately 10 years ago.The patient was asymptomatic, however during a medical exam it was found that one of the screws (left l3).6x45 fas screw has broken, leaving the head unattached from the shaft.The contralateral rod was also broken, meaning that a cross connector had to be added to the construct to attach a smaller rod to the lower construct.Two screws had to be revised during the procedure.Both the patient and surgeon have requested that this is investigated and would like to be informed of the outcome.The patient was revised 10 years after her initial surgery.Fragments were not generated.Patient status: fit and well.This report is for one (1) exp dual-inner setscrew.This is report 2 of 3 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.D2b: additional product code: kwq,osh,mni, mnh, kwp.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.H10 additional narrative: h3, h4, h6 investigation summary the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that exp dual-inner setscrew was broken and signs of wear which could have been a result of implantation and explantation.Fragment was not received in the visual evidence provided.No other issues were identified.The implants are designed to be used as an adjunct to fusion.Per the ifu, ¿even if solid bone fusion occurs, implant components may nevertheless bend, break, or loosen.Additionally, metallic implants cannot be made to last indefinitely.Their purpose is to provide temporary internal support while the fusion mass is consolidating.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for exp dual-inner setscrew.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.Device history the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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: EXP DUAL-INNER SETSCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18610208
• MDR Text Key: 334139916
• Report Number: 1526439-2024-00771
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034268453
• UDI-Public: (01)10705034268453
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 179722000S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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: EXP DI FAR SCREWS 6.00 X 45; EXP TI CP ROD, 600 MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female