MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 279712580

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, that the reducer would not articulate, and upon inspection it was discovered that is was jammed.There was a reported surgical delay of two (2) minutes.Another reducer was used to complete the procedure.The procedure was completed successfully.There were no fragments generated.There was no reported consequence to the patient.This report involves one (1) expedium spine system clip-on red.Driver w/dovetail 5.5mm.This is report 1 of 1 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10408140
• MDR Text Key: 202949265
• Report Number: 1526439-2020-01481
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034199009
• UDI-Public: (01)10705034199009
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279712580
• Device Catalogue Number: 279712580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• 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