MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SET SCREW T27; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	5560010000
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
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 narrative: d4: udi: as the lot number for the device involved in the event was not provided, 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.
Event or Problem Description
It was reported that on an unknown date, the rod from a trialtis screw slipped out.The set screw stayed in the screw; however the rod came out.The surgeon admitted that it was likely user error but wanted to have the screw and cap checked out.Patient underwent hardware/explant removal on (b)(6) 2025 to fix the rod and set screws.There was no patient status/ outcome / consequences.Implant date: (b)(6) 2025.Explant date: (b)(6) 2025.
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 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, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found signs normal of explanation and implantation process.No signs of manufactured defects or anything that could help to the malfunction of the device.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed several attempts of assemble and disassembly were made.It was possible to preformed the complete assembly process, the mating devices used were returned also in this complaint (5560553095t, ti lrdsd rod 5.5 x 95mm and 5560126050f, poly screw, fen, 6mm x 50) and no malfunction in the assemble process were found.Once the assembly process was complete the devices moved strongly to see if the loose condition was present.The assembly work as expected.However, due the photograph evidence provided by the customer, the complaint allegation can be confirmed.Therefore, the potential cause is traced to user due to the information mentioned in the event description and the investigation findings.The overall complaint was confirmed as the observed condition of the set screw t27 would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to user, 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.Dece history lot: part# 5560010000.Lot # 417228.Manufacturing site: depuy synthes.Supplier: (b)(4).Release to warehouse date: 18 nov 2024.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SET SCREW T27
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 21899276
• Report Number: 1526439-2025-00536
• Device Sequence Number: 14311331
• Product Code: NKB
• UDI-Device Identifier: 10705034589664
• UDI-Public: (01)10705034589664(10)417228
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5560010000
• Device Lot Number: 417228
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 05/13/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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