MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 13G X 4 INCHES; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	283903413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Part/lot combination is not valid, therefore the dhr could not be completed.If the device is returned or the lot number is confirmed the dhr will be revisited.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 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 or Problem Description
Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2022, the needle would not come out after the application of cement.The surgeon tried to remove it by himself, and the needle broke.The broken fragment was taken out through the laminectomy incision.An x-ray was performed, and no fragments were seen in the vertebra.The patient had a metastatic tumor on the spine with hard bone.The surgeon passed the needle until the middle of the vertebral body and could not advance it any further, so he decided to inject confidence spinal cement.Surgery was delayed because they had to pass other equipment to be able to remove the fragment.This report involves one confidence spinal cement system introducer needle, diamond tip 13g x 4 inches.This is report 1 of 1 for (b)(4).

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 13G X 4 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: 15487261
• Report Number: 1526439-2022-01674
• Device Sequence Number: 1995668
• Product Code: GAA
• UDI-Device Identifier: 10705034209463
• UDI-Public: 10705034209463
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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

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 Model Number: 283903413
• Device Catalogue Number: 283903413
• Device Lot Number: 340831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BIOMATERIAL - CEMENT
• Patient Age: 56 YR
• Patient Sex: Male