MAUDE Adverse Event Report: DEPUY SPINE INC XPDM PEDICLE PROBE, STRAIGHT

Model Number 279702010

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/31/2022

Event Type  Injury  

Event Description

It was reported on (b)(6) 2022, during lumbar fusion procedure, while using the pedicle probe out of the expedium offset instruments, the instrument broke intraoperatively.The surgeon took a x-ray to see the fragment, the tip of the device about 1 cm long embedded in the patient.The decision was made by surgeon to leave the broken tip in and place the pedicle screw in next to the broken part.Fragments were generated.There was no surgical delay.The procedure was completed successfully.Patient outcome was fine.Concomitant device reported: unknown screws (part# unknown; lot# unknown; quantity: unknown).This is report 1 of 1 for (b)(4).This report is for a pedicle probe.

Manufacturer Narrative

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.

• Brand Name: XPDM PEDICLE PROBE, STRAIGHT
• Type of Device: PROBE
• 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: 14833345
• MDR Text Key: 294946643
• Report Number: 1526439-2022-00951
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198415
• UDI-Public: (01)10705034198415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279702010
• Device Catalogue Number: 279702010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• 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: 52 YR
• Patient Sex: Male