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

Model Number 279726500

Device Problem Break (1069)

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

Event Date 06/03/2022

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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 synthes reports an event in japan as follows: it was reported on (b)(6) 2022, that this was a plif (l3-5) for treating spinal canal stenosis due to spondylolytic spondylolisthesis on (b)(6) 2022.Cement was applied to l3 and l5.After expedium fenestrated screws and a proti t-pal cage were deployed, an alignment guide was placed.The 1st cannula broke off when they tried to confirm if the cannula could be attached to the alignment guide.They tried the 1st replacing cannula, but the alignment guide came off a few times.The 2nd cannula also broke off while those device were being attached together.The cement became harder during the aforementioned events.When they tried the 2nd replacement, the cement to be applied at l5 had higher viscosity.The hardened cement prevented the 2nd replacing cannula from advancing.As extra cannulas were out of stock in the hospital, they held the procedure in abeyance for 60 minutes until extra cannulas newly arrived.The procedure was completed with further replacements.No further information is available.This report is for one (1)fen open cannula strl.This is report 2 of 4 for complaint.

• 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: 14875398
• MDR Text Key: 302782701
• Report Number: 1526439-2022-00966
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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: LC37579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1