MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR OC PLATE MEDIUM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 188362037

Device Problem Break (1069)

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

Event Date 11/24/2023

Event Type  malfunction  

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.D2b: additional product codes: kwp and mni.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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

It was reported that on (b)(6) 2023 during a occipito cervical fusion procedure of c5 with mountaineer oct, a oct plate was measured and selected.It was attempted to follow procedure of contouring, at the back table, the superior tip of the plate (at bending zone) with the oct plate bender.With gentle pressure to bend, the tip of the plate snapped off at bending zone.New plate was selected (37mm) and was able to properly bend the plate to proceed.The procedure was successfully completed.There was no patient consequences.This report is for one (1) mntr oc plate medium 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.A review of the receiving inspection (ri) for mntr oc plate medium, was conducted identifying that lot number wa25120 was released in one batch batch1: lot qty of (b)(4) units were released on oct 14 2019 with no discrepancies.Supplier: depuy: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 mntr oc plate medium was found broken from one of the tabs.The broken fragment was returned for examination.This finding confirms the photographic evidence.A dimensional inspection was unable to be 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 mntr oc plate medium would contribute to the complained device issue.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MNTR OC PLATE MEDIUM
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW 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 ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 18335827
• MDR Text Key: 331058131
• Report Number: 1526439-2023-02564
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034158884
• UDI-Public: (01)10705034158884
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 188362037
• Device Lot Number: WA25120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OC PLATE BENDER
• Patient Sex: Female