|
Model Number 279702040 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/28/2019 |
Event Type
malfunction
|
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 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.
|
|
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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).
|
|
Search Alerts/Recalls
|
|
|