MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS CANNULATED X-TAB 6X40MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186760040
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in denmark as follows: it was reported on (b)(6) 2023, that is not possible to place insertion sleeve (b)(4) over the screw extensions prior to insertion in patient.When the extensions on the screws are inserted approximately 1 cm the screw gets stuck in the insertion sleeve.This has been tested on the account managers own demo sleeve.Surgery was performed as planned.No consequence for patient.This report is for one (1) mis cannulated x-tab 6x40mm ti.This is report 1 of 2 for complaint (b)(4).
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.Additional product code: mnh, kwq,kwp,nkb,osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.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, a follow-up will be filed as appropriate.
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.H4: manufacture date added.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 mis cannulated x-tab 6x40mm ti had the tabs slightly bent outwards from the proximal section.A dimensional inspection was performed for the mis cannulated x-tab 6x40mm ti and the outer diameter resulted out of specification at the proximal tip in comparison to the distal section, confirming the bending condition of the tabs.A functional test was unable to be performed since the insertion sleeve was not returned.However, the bent condition of the device can contribute to the device interaction issues.The complaint condition was not able to be replicated.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 mis cannulated x-tab 6x40mm ti 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.Device history lot a manufacturing record evaluation was performed for the finished device product code: 186760040s lot number: 349854 it was electronically reviewed no non-conformances /manufacturing irregularities related to the malfunction were identified.The product was released on: 25/08/2022 qty: (b)(4).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.D10: date of concomitant therapy is (b)(6), 2023.
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.(b)(4).H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MIS CANNULATED X-TAB 6X40MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE 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: 16352993
• Report Number: 1526439-2023-00228
• Device Sequence Number: 7029889
• Product Code: MNI
• UDI-Device Identifier: 10705034129198
• UDI-Public: (01)10705034129198
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Model Number: 186760040
• Device Catalogue Number: 186760040
• Device Lot Number: 349854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/20/2023; 03/16/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/09/2023; 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS CANNULATED X-TAB 6X45MM TI.
• Patient Sex: Unknown