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

Model Number	279702010
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1526439-2022-00951
• Device Sequence Number: 4832916
• Product Code: HXB
• UDI-Device Identifier: 10705034198415
• UDI-Public: (01)10705034198415
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: 279702010
• Device Catalogue Number: 279702010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male