MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX XTAB 6X40MM TI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 186760340S

Device Problem Device Slipped (1584)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was a psf (t8-l2) for a t11 vertebral body fracture on (b)(6) 2023.When the surgeon inserted the screw into the left t9 with the screwdriver, the connection between the screw and screwdriver became loose.The surgeon removed the screw and screwdriver because he felt strange in the direction in which the screw was inserted.There was no abnormality in the screwdriver, and no damage was observed on the external appearance of the screw.After that, the screwdriver was able to be used without any problems.Therefore, it seems that there was some kind of problem with the screw.The surgeon inserted a substitute screw and completed the fixation as usual.The surgery was completed successfully with about 5 minutes delay, and there was no impact on the patient.No further information is available.Concomitant device reported: unk - screwdrivers (part# unknown, lot# unknown, quantity# unknown) this report is for one (1) viper prime cfx xtab 6x40mm ti 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: kwp,kwq,osh,mni and mnh.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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: h6: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.D4, h4, h6: a manufacturing record evaluation was performed for the finished device product code : 186760340s.Lot number : tbagpb.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 08/09/2021.Manufacturing site:jabil le locle.Expiry date:31/07/2026.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: VIPER PRIME CFX XTAB 6X40MM TI
• Type of Device: THORACOLUMBOSACRAL PEDICLE 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: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 17894839
• MDR Text Key: 325630481
• Report Number: 1526439-2023-01956
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034530017
• UDI-Public: (01)10705034530017
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 186760340S
• Device Lot Number: TBAGPB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: VIPER.