MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X18; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	102035118S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that patient underwent a cervical spinal procedure (posterior).After drilling with a 2.4mm drill in the lateral mass of c5 left side, a symphony screw 3.5/18mm broke off during insertion in the lateral mass.The broken off part was stuck in the lateral mass.It was taken out of the bone in two steps with a tool.Two steps were necessary because the broken tip broke once more during extraction.After all of the screw tip was taken out, the hole was tapped with a 3.5 tap and then a 3.5mm/16mm screw was inserted.Procedure was completed successfully with a fifteen minute delay.There is concern that fixation may not have been optimal.Patient was okay following surgery.
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.H11 additional narrative: added: d9 and h4.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the 4.0 ply scrw 3.5x18 stuck into the mating device confirming the broken allegation.No other finding can be seen for this device a dimensional inspection was not performed due to post manufacturing damage.A functional evaluation was performed trying to unsuccessfully disassemble the device from the mating device.The overall complaint was confirmed as the observed condition of the 4.0 ply scrw 3.5x18 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition hence the root cause cannot be established.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a dhr evaluation was performed for the finished device product code: 102035118s.Lot number: 423514.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 11-mar-2025.Manufacturing site: jabil le locle.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: 4.0 PLY SCRW 3.5X18
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• 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: elba bello ; chemin blanc 38; le locle ; SZ ; 9083863534
• MDR Report Key: 22844275
• Report Number: 1526439-2025-01073
• Device Sequence Number: 9463516
• Product Code: NKG
• UDI-Device Identifier: 10705034524399
• UDI-Public: (01)10705034524399(17)300131(10)423514
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102035118S
• Device Lot Number: 423514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female