MAUDE Adverse Event Report: DEPUY SPINE INC XPDM THORACIC PEDICLE PRB, CRV; PROBE

Model Number	279702040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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) 2019, during a posterior spinal fusion on a patient with hard bone, while creating a pathway for the screw into the pedicle, the thoracic probe broke at the distal end tip.This piece was retrieved and nothing was left inside the patient.Also, when doing final tightening, the torque driver shaft stripped at the distal end tip.There were fragments generated but was easily removed.The procedure was completed successfully.The patient did not suffer due to these brakes.Concomitant device reported: unknown polyaxial screw (part # unknown, lot # unknown, quantity# unknown).This complaint involves two (2) devices.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the fracture was located at 40mm from the probe¿s tip.The second half of the probe¿s tip was also returned.The fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the instrument underwent a static failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A definitive root cause for the probe¿s distal tip fracturing cannot be positively determined.However, the fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the instrument underwent a static failure due to a single, sudden, unexpectedly high force placed on the tip of the device.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: XPDM THORACIC PEDICLE PRB, CRV
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8705160
• Report Number: 1526439-2019-51769
• Device Sequence Number: 13922338
• Product Code: HXB
• UDI-Device Identifier: 10705034198446
• UDI-Public: (01)10705034198446
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2019

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: NW136373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 08/14/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/09/2019; 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1