MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SFX,5.5,TI, LAT, SIZE A3; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 189401303

Device Problems Mechanical Problem (1384); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in korea, south as follows: it was reported on (b)(6) 2023, that in the process of tightening the socket nut, wear occurred, preventing the next step from being carried out.It is unknown if the surgery was delayed due to the reported event.Is unknow if the procedure was successfully completed.This report is for one (1) sfx,5.5,ti, lat, size a3.This is report 1 of 2 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 codes: osh,kwp,mni,kwq and mnh.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.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.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 set screw of the sfx,5.5,ti, lat, size a3 was found stripped.The will not tension allegation can attribute to the stripped condition.A dimensional inspection was not 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.The overall complaint was confirmed as the observed condition of the sfx,5.5,ti, lat, size a3 [189401303/om12034] wouldt 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed dwg-1894-01-301/305 rev f current & manufactured.Dimensional inspection: n/a.H4, h6: a review of the receiving inspection (ri) for sfx,5.5,ti, lat, size a3, was conducted identifying that lot number om12034 was released in one batch.Batch1: lot units were released on 31 oct 2022 with no discrepancies.Supplier : (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.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

The surgery was successfully completed.Patient status/outcome: n/a.No broken fragments were retained in the patient.

• Brand Name: SFX,5.5,TI, LAT, SIZE A3
• 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: 18411493
• MDR Text Key: 331705947
• Report Number: 1526439-2023-02643
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034168036
• UDI-Public: (01)10705034168036
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 189401303
• Device Lot Number: OM12034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SFX,5.5,TI, LAT, SIZE A2