MAUDE Adverse Event Report: DEPUY SYNTHES SPINE XPDM THORACIC PEDICLE PRB, ST; PROBE

Catalog Number 279702030

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Account name: (b)(6) hospital.On (b)(6) 2017, surgery for degenerative lumbar spondylolisthesis was performed using the expedium system.The fixed area was l3-l5.During the surgery, the following device got broken at the time of making a screw hole.Xpdm thoracic pedicle prb, st (part#: 279702030, lot#: m22).The surgery was completed without any delay, and there was no adverse consequence to the patient.We are required to submit an investigation report as to why this device got broken.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination of the returned device noted the fracture was located 40mm from the probe¿s distal tip.Device was then sent for fracture analysis.The fracture analysis report shows rough grainy appearances consistent across the entirety of the surface with no evidence of fatigue striations.This suggest that the probe tip underwent a quasi-static overload failure.No material defects or other abnormalities have been identified in the fracture analysis report.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 trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the probe¿s distal tip becoming fracture cannot be positively determined.However, the fracture analysis report suggest that the probe tip underwent a quasi-static overload failure.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 and no systemic trends were found, 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.

• Brand Name: XPDM THORACIC PEDICLE PRB, ST
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7082968
• MDR Text Key: 94891632
• Report Number: 1526439-2017-50041
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198439
• UDI-Public: 10705034198439
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 279702030
• Device Lot Number: 0905V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1