MAUDE Adverse Event Report: DEPUY SPINE INC CONF INTRO NDLE, DIA, 13G 4"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number 283910000

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

Reporter is a synthes employee.Product code: 283910000, lot: 306526, the dhr was electronically reviewed and a non-conformance has been observed during the manufacturing process with no link with complaint description.The product was released on: 29.07.2021.Qty: (b)(4).Photo investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, the needle shaft was observed to be broken.However, the reported condition of fragments remaining in the bone cannot be confirmed from the provided images.The root cause for the reported event cannot be determined from the available information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the specialist inserted the needle into the patient's bone.The cement was applied and during the removal of the needle from the bone the specialist made circular movements to the needle which has split.A fragment remained in the patient's bone.This report is for 1 confidence spinal cmt sys, 11c.This is report 1 of 1 for (b)(4).

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.The complaint device (needle) is a subcomponent of the following kit.Product code: 283910000 lot: 306526 the device history record (dhr) was electronically reviewed and no relevant non-conformance's were observed.The product was released on: july 29, 2021.Visual inspection: the conf intro ndle, dia, 13g 4" was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the needle shaft was broken into two pieces.The broken end fragment was not returned with the device.The reported complaint condition of the broken fragment remaining in the patient cannot be confirmed as no post operative radiographic images were provided.No other issues were found with the device.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to post manufacturing damage.Document/specification review: the following drawing(s) was reviewed: - confidence introducer needle, diamond tip 13g 6" (current and manufactured to) no design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint is being confirmed for the conf intro ndle, dia, 13g 4".A definitive root cause could not be identified for the reported issue from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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 was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONF INTRO NDLE, DIA, 13G 4"
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12688492
• MDR Text Key: 278105231
• Report Number: 1526439-2021-02239
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 10705034209623
• UDI-Public: 10705034209623
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283910000
• Device Catalogue Number: 283903413
• Device Lot Number: 306526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention