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 Codes	Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 (b)(6) reports an event as follows: it was reported that on an unknown date during a kyphoplasty procedure, two needles were inserted into the patient's vertebrae (bi-lateral approach).After inserting the needles, the surgeon decided to switch the needles to the ones in the synflate kit in order to use a balloon.The needles got stuck in the patient's vertebrae and a lot of force was used to try to get them out.One (1) needle came out and the other one (1) detached from the handle because of the force that was used.While pulling the needle out it broke and an open procedure needed to be performed.After preforming a small incision, the surgeon reached the base of the vertebrae and pulled whatever he could from the needle.A part of the needle remained in the vertebrae.In addition, after inserting the synflate's balloon and inflating it, the balloon ripped and failed under the pressure (although the bar didn't reach the maximum level permitted).There was a surgical delay of one (1) hour.This report is for one (1) confidence spinal cement system introducer needle, diamond tip 13g x 4 inches.This is report 1 of 2 for (b)(4).This report is related to (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
• MDR Report Key: 11776932
• Report Number: 1526439-2021-00894
• Device Sequence Number: 14439689
• Product Code: GAA
• UDI-Device Identifier: 10705034209463
• UDI-Public: 10705034209463
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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 Model Number: 283903413
• Device Catalogue Number: 283903413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2021
• Initial Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONFIDENCE SPINAL CMT SYS, 11C; UNKNOWN INSERTION INSTRUMENTS
• Outcome Attributed to Adverse Event: Required Intervention