MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 6 X 50MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 186715650

Device Problem Material Deformation (2976)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: d2: additional procodes: kwq, mni, mnh, osh, nkb.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthese employee.H3, h4, h6: 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.The photo was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that mis cann poly scw 6x50mm,ti had signs of stripped at the surface head, where it is screwed on by the screwdriver.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 synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for mis cann poly scw 6x50mm.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 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

Device report from russia reports an event as follows: it was reported that during surgery on (b)(6) 2023, the screwdriver from the viper 2 broke, and the screw could not be implanted, possibly due to a problem with the screwdriver.The screw was deformed.The set of products was issued by orthokit.There were no casualties.This report is for a viper system cannulated polyaxial screw 5.5 x 6 x 50mm.This is report 2 of 2 for (b)(4).

Event Description

The procedure was completed successfully with no surgical delay.There was no adverse patient impact.

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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 6 X 50MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 17049795
• MDR Text Key: 316406069
• Report Number: 1526439-2023-00969
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10705034122366
• UDI-Public: (01)10705034122366
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 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: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186715650
• Device Catalogue Number: 186715650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• 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: POLY SCW DRIVER SHFT, CANNULTD