MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 SHAFT PLY SCRW 3.5X30; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	102035730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Additional 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.Additional narrative: d2: additional procodes: hrs, hwc, kwp.H3, h6: a manufacturing record evaluation was performed for the finished device product code: 102035730.Lot: 328160 it was electronicall.Y reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 09-november-2021.Manufacturing site: jabil le locle.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 4.0 shaft ply scrw 3.5x30 was broken at the shaft, the broken surface was examined and there was no evidence of a material issue.Fragment was not received for evaluation.A dimensional inspection for the 4.0 shaft ply scrw 3.5x30 was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 4.0 shaft ply scrw 3.5x30 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.Drawing/specifications reviewed.The following source controlled drawings reflecting the current and manufactured revisions were reviewed: 103140293 shaft polyscrew, 4.0 rod, 3.5x18-50.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 or Problem Description
It was reported that patient underwent revision surgery on (b)(6) 2024, due to broken 3.5mm shaft poly screws.Patient originally underwent a spine procedure on (b)(6) 2023.This report is for a 4.0 shaft ply scrw 3.5x30.This is report 1 of 2 for (b)(4).

• Brand Name: 4.0 SHAFT PLY SCRW 3.5X30
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19626157
• Report Number: 1526439-2024-01714
• Device Sequence Number: 20441622
• Product Code: NKG
• UDI-Device Identifier: 10705034513706
• UDI-Public: (01)10705034513706
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102035730
• Device Lot Number: 328160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown