MAUDE Adverse Event Report: STRYKER SPINE-US CANNULATED PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number IS3013XLP

Device Problems Bent (1059); Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2018

Event Type  malfunction  

Event Description

It was reported that while accessing pedicle with the specialty cannulated probe with trocar, surgeon was using mallet to advance probe with trocar inserted, when the tip of the probe bent, causing trocar to be pinched.When attempting to remove inner trocar to insert k wire, inner trocar broke.There are no reports of adverse consequences to the patient.

Manufacturer Narrative

Method: visual inspection, material analysis, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The probe was returned in 3 pieces.The device was sent for material analysis.The k wire was found to have fractured in a mixed mode overload.The fracture surface was heavily damaged and no fracture origin was found.The sleeve and the k wire were found to meet the elemental constituents and hardness specified on the print.No material or manufacturing defects were found.Conclusion: the most likely root cause of the event is excessive force applied to the instrument due to the patient's very hard bone quality, causing the tip to deform and the trocar to jam, which was then fractured when excessive force was applied to the trocar in an attempt to remove it.

Event Description

It was reported that while accessing pedicle with the specialty cannulated probe with trocar, surgeon was using mallet to advance probe with trocar inserted, when the tip of the probe bent, causing trocar to be pinched.When attempting to remove inner trocar to insert k wire, inner trocar broke.There are no reports of adverse consequences to the patient.

• Brand Name: CANNULATED PROBE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7480239
• MDR Text Key: 107352789
• Report Number: 3004024955-2018-00027
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327279474
• UDI-Public: (01)07613327279474
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

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
• Device Operator: Health Professional
• Device Model Number: IS3013XLP
• Device Catalogue Number: IS3013XLP
• Device Lot Number: 24652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1