MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	283903611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
It was reported that the surgeon performing an l5-s1 fusion, wanted to use jamshedi/probe to tap into bone before placing a guidewire over which he would place cortical fix screw.Hospital had none of their usual kits as they are now discontinued, so now the only option was to use the jamshedi/probe.Surgeon used toffee hammer to tap in the cannula, the t-handle at top of cannula snapped off so removed the inner part to place guidewire.The outer tube of cannula could then not be removed and was crushed when using a ¿bone nibbler¿ to try and pull it out.Surgeon was snapping off small parts in an attempt to remove it.The tube was too crushed to pass the inner part back down to give it some rigidity.After a further 40 minutes and the assistance of a burr, the surgeon was able to drill down the side of the broken piece and remove the last bit of cannula.Scrub team and sales representative confirmed that it was the full tip as compared side by side to another cannula.An additional hour was added to the case due to the event.Hospital has since sourced new replacement of their disposable probes.They have also added viper 2 cannulated pedicle probes with stylets to have the reusable version available if required.
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.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h4, 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.Device history review: a manufacturing record evaluation was performed for the finished device.Product code: 283903611.Lot number: 416453.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 15 nov 2024.Manufacturing site: jabil le locle.Expiry date: 30 sep 2029.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G X 6 INCHES
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21274947
• Report Number: 1526439-2025-00137
• Device Sequence Number: 20850667
• Product Code: GAA
• UDI-Device Identifier: 10705034209494
• UDI-Public: (01)10705034209494(17)290930(10)416453
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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: 283903611
• Device Lot Number: 416453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2024
• 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 Sex: Unknown