MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PROBE

Catalog Number 8350294

Device Problem Break (1069)

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

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during thoraco-lumbar fusion surgery, the probe broke by an inch while the surgeon was fighting a very sclerotic bone.No fragment of the broken probe remained inside the patient.No more information is available yet.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The broken probe was replaced with another one to complete the procedure.No patient complications were reported due to this event.

Manufacturer Narrative

Product analysis: visual and optical inspection confirmed the probe was returned with approximately 38mm of the tip broken off.The broken off portion of the shaft was not returned for evaluation.The angle on the face of the fracture surface is consistent with bend stress overload.The material hardness of the probe shaft was checked and meets print specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROBE
• Type of Device: PROBE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8971628
• MDR Text Key: 156816919
• Report Number: 1030489-2019-00995
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8350294
• Device Lot Number: SW10J044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1