MAUDE Adverse Event Report: DEPUY SPINE INC FEN OPEN CANNULA STRL; DISPENSER, CEMENT

Model Number 279726500

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, during a percutaneous posterior spinal fusion (th12) for burst fracture the cement and fenestrated screws were used for the treatment.Cement was planned to use in 4 spots.In the preoperative meeting, it was decided to inject cement into 1 spot at a time, so the open cannula in question was prepared in the surgical field at first.To prevent cement leakage, the surgeon carefully judged the viscosity of the cement, which did not easily reach the viscosity specified by the society, and cement injecting was started after fifteen(15) minutes and thiryt(30) seconds after mixing.At the stage of injecting cement into the 1st spot, a syringe was very stiff to push.At the 2nd stage of injecting cement into the spot, the syringe could not be pushed at all.The cement filled in another syringe was still soft to use when checked.Therefore, the surgeon used another new open cannula and tried to push the syringe that had been used before, but the syringe could not be pushed.At this point, twenty-one(21) minutes had passed from the mixing of the cement, and the sales rep suggested the surgeon to mix new cement.The new cement was injected into the 2nd to 4th spots which fenestrated screw was replaced because a little cement had been injected and remained in the fenestrated screw.Procedure was completed successfully with thirty(30) minutes of surgical delay.After surgery, the surgeon and sales rep discussed about the causes of the event, and the following possibilities were considered: cement injection started too late.The surgeon was too cautious and waited too long for the cement to get proper viscosity.Room temperature control was not thorough.The setting was set at the recommended 23°c, but it was unclear what the actual room temperature was.When the open cannula in question was replaced, the adapter was not replaced together, so the cement in the new open cannula could not inject cement at all because the cement that had been in the adapter had entered to the new open cannula.Postoperative visual observation of the new open cannula revealed that the cement had not reached the tip of the new open cannula and was lodged in the middle of the new open cannula.No further information is available.This report is for one (1) expedium spine system fenestrated screw open cannula 16g x 160mm.This is report 1 of 1 for complaint (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.H10 additional narrative: h3, h4, h6: a review of the receiving inspection (ri) for fen open cannula strl,was conducted identifying that lot number lc39064 was released in one batch.Batch1: lot qty of (b)(4) units were released on sep 1, 2022 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that fen open cannula strl the tip of the cannula has broken off at the weld from the cone at the midsection of the cannula.Assembling issues are most likely due to this condition.Fragment was received in the evidence provided.No other issue was identified.A dimensional inspection for the fen open cannula strl was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the fen open cannula strl would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that 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.

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.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FEN OPEN CANNULA STRL
• Type of Device: DISPENSER, CEMENT
• 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: 16752629
• MDR Text Key: 313427718
• Report Number: 1526439-2023-00691
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10705034199528
• UDI-Public: (01)10705034199528
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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
• Device Operator: Health Professional
• Device Model Number: 279726500
• Device Catalogue Number: 279726500
• Device Lot Number: LC39064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 04/29/2023; 05/22/2023
• Supplement Dates FDA Received: 05/15/2023; 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICES.