MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 13G X 6 INCHES; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	283902613
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.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.(b)(4).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 (b)(6) 2020 during a vertebroplasty of a metastasized vertebral body in a (b)(6) year-old tumor patient, the handle of the confidence needle broke when trying to remove it after the cement application.The shaft got stuck in the patient and could only be removed with the help of forceps, the assistance of an accident surgeon, considerable additional expenditure of time and radiation exposure for the patient.There was a surgical delay of forty-five (45) minutes.The procedure was completed successfully.This report is for one (1) confidence spinal cement system introducer needle, beveled tip 13g x 6 inches.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
H10 additional narrative: the dhr of product code: 283902613 lot : 265397 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 15.12.2019 qty: 128 visual inspection: the conf intro ndle, bev, 13g 6" (part #: 283902613, lot #: 265397) was received at us customer quality (cq).Upon visual inspection, the confidence spinal cement system needle was broken in two places.The first place of the breakage occurred at the connection with the t handle and the second breakage at the midshaft of the needle.The broken needle was also bent and crushed at toward the distal tip.Device failure/defect identified? yes.Dimensional inspection: no dimension was performed due to the post manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes investigation conclusion: this complaint is confirmed as the as received condition of the conf intro ndle, bev, 13g 6" (part #: 283902613, lot #: 265397) showed that the needle was broken into two places.The first place being at the connection with the t handle and the second breakage at the shaft closed to the distal end.Also the broken needle was also bent and crushed toward the distal tip.No definitive root cause could be determined based on the provided information but it is likely the breakage and bending were due to excise forces applied to the device and the crushed distal tip due to the pressure applied by the pliers during removal.No new, unique or different patient harms were identified as a result of this evaluation.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 on the investigation findings, it has been determined that no corrective and/or preventive 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: CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 13G X 6 INCHES
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10448117
• Report Number: 1526439-2020-01515
• Device Sequence Number: 3558306
• Product Code: GAA
• UDI-Device Identifier: 10705034209449
• UDI-Public: 10705034209449
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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 Expiration Date: 11/30/2024
• Device Model Number: 283902613
• Device Catalogue Number: 283902613
• Device Lot Number: 265397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR