MAUDE Adverse Event Report: DEPUY SPINE INC. 5MM TAP, DUAL LEAD CANN; STEREOTACTIC SURGERY SYSTEM PROBE, REUSABLE

Model Number 286715500N

Device Problem Break (1069)

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

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 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.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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.

Event Description

This is report 1 of 2 for (b)(4).It was reported that by the sales rep that during a spinal fusion procedure on (b)(6) 2022, while tapping for a pedical screw, it was observed that the 6mm tap snapped by 1 cm from the tip while removing it from the bone.According to the report, while tapping another pedical with a 5mm tap, it was observed that the tap snapped 1 cm from the tip while removing it.All the fragments were removed.There was a surgical delay of two hours.There were no adverse patient consequences reported.No additional information was provided.This report is for one (1) 5mm tap, dual lead cann device.This complaint involves two (2) devices.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Reporter is a synthese employee.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: 5MM TAP, DUAL LEAD CANN
• Type of Device: STEREOTACTIC SURGERY SYSTEM PROBE, REUSABLE
• 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: 14253246
• MDR Text Key: 290446873
• Report Number: 1526439-2022-00642
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388489
• UDI-Public: 10705034388489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286715500N
• Device Catalogue Number: 286715500N
• 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
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MOD CANNULATED 6MM TAP
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male