MAUDE Adverse Event Report: DEPUY SPINE INC SINGLE-INNER SETSCREW; FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	179702000S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
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.H11 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.E1: initial reporter facility address: (b)(6).
Event or Problem Description
It was reported that during a spinal fusion surgery, the looking set screw became stripped and could not be used.It was replaced with a new one, with no consequences for the patient.The procedure was completed successfully with no 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.H11 additional narrative: added: d4 (lot, expiry date), g1, h4.Corrected: d4 primary udi number.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation was performed for the finished device.Product code: 179702000s.Lot number: 408940.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 19 sep 2024.Manufacturing site: jabil le locle.Expiry date: 31 aug 2029.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SINGLE-INNER SETSCREW
• Common Device Name: FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 21909336
• Report Number: 1526439-2025-00546
• Device Sequence Number: 14474289
• Product Code: NKB
• UDI-Device Identifier: 10705034265063
• UDI-Public: (01)10705034265063(17)290831(10)408940
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200245
• 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

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: 179702000S
• Device Lot Number: 408940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Male