MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X16; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	102035116
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, a patient underwent a procedure to remove broken hardware.During removal procedure it was discovered that five of the ten symphony screws had sheared off.The surgeon could not retrieve the broken half of the screw and it was left inside the patient.There was no surgical delay.
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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.H6: product was not returned.Based on the information available, it has been determined that no corrective and 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 history review (dhr): a manufacturing record evaluation was performed for the finished device product code: 179713003.Lot number: 300937.It was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 23-feb-2021.Manufacturing site: jabil le locle.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.H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 4.0 ply scrw 3.5x16 was found broken across the screw neck the fracture face was examined and no material issues were identified.The overall appeareance of the head screw present marks caused by the handling during the procedure.The shaft was not received for evaluation.Embedded condition of the fragment cannot be confirmed as x-ray images were not provided.A dimensional inspection for the 4.0 ply scrw 3.5x16 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, however; with the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 4.0 ply scrw 3.5x16 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.Device history review (dhr): a manufacturing record evaluation was performed for the finished device product code: 179713003 lot number: 300937 it was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 23-feb-2021 manufacturing site: jabil le locle.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.0 PLY SCRW 3.5X16
• Common Device Name: 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 ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 20419971
• Report Number: 1526439-2024-02662
• Device Sequence Number: 8400787
• Product Code: NKG
• UDI-Device Identifier: 10705034508702
• UDI-Public: (01)10705034508702(10)300937
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102035116
• Device Lot Number: 300937
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 10/30/2024; 12/19/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/22/2024; 11/08/2024; 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown