MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 7.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725740S

Device Problems Device Slipped (1584); Compatibility Problem (2960)

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

Event Date 01/19/2024

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was an interbody fusion performed on (b)(6) 2024.In the surgery, after tightening the set screw in question with a versex 25 set screwdriver, the head of the screw in question moved.It could not be determined whether the problem was on the screw side, the set screw, or whether the head appeared to have moved due to a loose screw.The screw and the set screw were replaced and final tightening was performed.The surgery was completed successfully within 30 minutes surgical delay.Patient status/ outcome: stable no further information is available.This report is for one (1) 5.5 exp verse can scr 7.0x40 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.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.

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: a manufacturing record evaluation was performed for the finished device product code: 199725740s.Lot no: 365543 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 28-feb-2023.Manufacturing site: jabil le locle.Expiry date: 31-jan-2028.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the head of the screw shows signs of damage.Both tabs of the cap screw were removed and not returned for evaluation.As well, the head of screw is stuck with screw cap; this must swivel on screw when manipulated.It is not unreasonable that the condition of the device can be related with correct functionality, therefore it is possible to confirm the reported issue of unable to assemble.However, loose condition cannot be confirmed with available information.The condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces when usage.Appropriate use of the device diminishes the risk of failure; the surgical technique guide was reviewed and the following relevant caution statements were found: caution: all set screw tightening must be performed using the torque limiting handle to ensure system torque is obtained and not exceeded.Not reaching or exceeding the system torque may result in failure of the implant.Caution: when final tightening, revisit set screws at every level, starting with the outer portion of the correction key working away from the levels which have been reduced the furthest.After revisiting the outer portion, perform the same action on the inner portion of all set screws at every level.A functional test can not be performed due to post manufactured damage.A dimensional inspection was unable to be performed due to post manufactured damage.The overall complaint was confirmed as the observed condition of the 5.5 exp verse can scr 7.0x40 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE CAN SCR 7.0X40
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 18641346
• MDR Text Key: 334965469
• Report Number: 1526439-2024-00816
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725740S
• Device Lot Number: 365543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TORQUE LIMITING HANDLE 80IN-LB; UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWDRIVERS; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER