MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE

Model Number	279702040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 or Problem Description
It was reported that on (b)(6) 2021, during an unknown procedure the surgeon was using the gear shift to probe the pedicle screws when the tip of the gear shift broke off into the patient at t1.The surgeon was able to remove the broken piece and insert the pedicle screw without any further problems.There was no surgical delay.There were no patient consequences.The procedure was successfully completed.This report is for a gear shift.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.H10 additional narrative: h3, h4, h6- the tip of the pedicle probe had been damaged and broken during surgery.The device also shows signs of wear consistent with usage.During investigation no manufacturing or design discrepancies were identified.A definitive assignable root cause cannot be determined from the provided information.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: a review of the receiving inspection (ri) for xpdm thoracic pedicle prb, crv was conducted identifying that lot number 0810nt was released in a single batch.Batch1: lot qty of units were released on 27 aug 2010 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.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: EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12327960
• Report Number: 1526439-2021-01706
• Device Sequence Number: 4712659
• Product Code: HXB
• UDI-Device Identifier: 10705034198446
• UDI-Public: (01)10705034198446
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 279702040
• Device Catalogue Number: 279702040
• Device Lot Number: 0810NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/25/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 08/19/2021; 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS