MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 STRAIGHT ROD480MM, COCR; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 196789480

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 04/20/2023

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that this pc is related to (b)(4) and (b)(4).This pc reports about the back pain and breakage of the rods occurred after the vcr performed on (b)(6) 2021.It was reported that after the vcr, when the patient twisted his/her back to get something from the refrigerator on (b)(6) 2023, he/she began to have back pain, which gradually worsened.On (b)(6) 2023, the patient was examined and found that the bilateral rods installed in 5/s were broken.On (b)(6) 2023, a reoperation was performed.No further information is available.This complaint involves two (2) devices.This report is for one (1) viper2 straight rod480mm, cocr.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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 pro-codes: kwp, osh, kwq, mni, nkb.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E1: state; (b)(6).E3: reporter is a j&j sales representative.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.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: d4.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: e1 h3, h4,h6 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 the viper2 straight rod480mm, cocr was broken in several fragments.The edges of the fractures were examined and there were no indications of material issues or anomalies.With the available information, it is not possible to establish a root cause for the breakage condition of the rods.Per the event description, it is possible that the devices got broken due to unintended forces when the patient twisted his/her back.A dimensional inspection for the viper2 straight rod480mm, cocr was unable to be performed due to post manufacturing damage.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 viper2 straight rod480mm, cocr 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 drawings reflecting the current and manufactured revisions were reviewed: - expedium/viper2 straight rod cobalt-chromium dwg- rev.E / rev.E dimensional inspection: n/a a review of the receiving inspection (ri) for viper2 straight rod480mm, cocr , was conducted identifying that lot number gm55481 was released in two batches.Supplier: seabrook medical batch1: lot were released on 11, may 2020 with no discrepancies.Batch2: lot units were released on 11 may 2020 with no discrepancies.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 d9.

• Brand Name: VIPER2 STRAIGHT ROD480MM, COCR
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• 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 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17088321
• MDR Text Key: 316803013
• Report Number: 1526439-2023-01031
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034295275
• UDI-Public: (01)10705034295275
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111136
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 196789480
• Device Catalogue Number: 196789480
• Device Lot Number: GM55481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VIPER2 STRAIGHT ROD480MM, COCR
• Patient Outcome(s): Required Intervention