MAUDE Adverse Event Report: DEPUY SYNTHES PEDICLE PROBE - CURVED

Catalog Number 2797-02-020

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2016

Event Type  malfunction  

Event Description

During surgery, the tip of the depuy synthes pedicle probe (about 10mm) broke off of probe and was stuck in pt's spine at lumbar 5.Multiple attempts were made to remove the tip of the probe but these attempt were not successful.Tip of probe remains in lumbar 5.

• Brand Name: PEDICLE PROBE - CURVED
• Type of Device: PEDICLE PROBE - CURVED
• Manufacturer (Section D): DEPUY SYNTHES
• MDR Report Key: 5979835
• MDR Text Key: 55886776
• Report Number: MW5065040
• Device Sequence Number: 1
• Product Code: HXB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2797-02-020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 104