MAUDE Adverse Event Report: BIOMET SPINE LLC / ZIMMER BIOMET NITINOL GUIDE WIRE / PEDICLE SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 14-500360

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2021

Event Type  malfunction  

Event Description

Guidewires were used to direct screws into the proper location in the pelvis.Upon attempted removal of the guidewires, the threaded tips of the guidewires on the right and left side fractured and were retained in the pelvic bone.

• Brand Name: NITINOL GUIDE WIRE / PEDICLE SCREW SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): BIOMET SPINE LLC / ZIMMER BIOMET; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 13306432
• MDR Text Key: 284114224
• Report Number: 13306432
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14-500360
• Device Catalogue Number: 14-500360
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4745 DA
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Hispanic