MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM; QUICK CONNECT SI POLYAXIAL SCREW DRIVER

Model Number 279712400

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: 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 a scoliosis correction was performed.The inserting a cfx screw the t20 screwdriver tips sheared off under a large amount of torque from mr turner and mr johnson.The tip was left in the screw within the patient.Rods and set screws were then placed in the screws and then final tightened as per the surgical technique.The screws were backed out slightly using a rod and set screw then final tightened.This was a satisfactory solution.2 minute delay to the procedure, no ae to patient.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM
• Type of Device: QUICK CONNECT SI POLYAXIAL SCREW DRIVER
• 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: 9413412
• MDR Text Key: 185475478
• Report Number: 1526439-2019-52565
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034198897
• UDI-Public: (01)10705034198897
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2019

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
• Device Operator: Health Professional
• Device Model Number: 279712400
• Device Catalogue Number: 279712400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR