MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	186731750
Medical Device Problem Codes	Break (1069); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, this was a tlif (lumbar) for spondylolisthesis.During surgery, the set screw could not be inserted into the cortical fix screw during set screw fastening.Therefore, the cortical fix screw was removed, another screw was inserted into the set screw, and the surgery was completed.The surgeon attempted to insert a set screw into the cortical fix screw even outside the patient's body but was unable to do so.The surgery was completed successfully within 30 minutes surgical delay.The patient was reported as stable.
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.H11 additional narrative: added: d9, h4 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 the initial medwatch, a follow-up medwatch 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the 5.5 ti cort fix 7x50mm had sign of rough handle along the head component.Additionally chipped broken was observed in different sections of the shank and the cap.It's possible to observed significant damage in the treads of the shank.However, the entire damaged surface was thoroughly examined and no problems with the material were found.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces due to the attempt of implantation into hard bone, which requires the application of significant torque for the implantation process.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to be performed, since the mating device was not returned.However the complaint allegation can be confirmed due to the damage observed on the device.The overall complaint was confirmed as the observed condition of the 5.5 ti cort fix 7x50mm would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device product code:186731750.Lot no: 397640 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 23-apr-2024.Manufacturing site: jabil le locle.

• Brand Name: VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 50MM
• Common Device Name: 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: 20292129
• Report Number: 1526439-2024-02592
• Device Sequence Number: 7995964
• Product Code: NKB
• UDI-Device Identifier: 10705034352022
• UDI-Public: (01)10705034352022(10)397640
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 186731750
• Device Lot Number: 397640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 11/28/2024; 12/12/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 12/04/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown