MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. NTINOL GUIDEWIRE 1.6MM X 510MM BLUNT; POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS

Catalog Number 14-500360

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3012447612-2022-00048.

Event Description

It was reported that upon attempted removal of cypher guidewires, the threaded tips of the guidewires on the right and left side fractured and were retained in the pelvic bone.Reference voluntary medwatch (b)(4).This is report two of two for this event.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos were not taken.Device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: dhr review was not performed as lot number is not known.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that upon attempted removal of cypher guidewires, the threaded tips of the guidewires on the right and left side fractured and were retained in the pelvic bone.Reference voluntary medwatch 0533020000-2021-8014.This is report two of two for this event.

• Brand Name: NTINOL GUIDEWIRE 1.6MM X 510MM BLUNT
• Type of Device: POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13563897
• MDR Text Key: 287790136
• Report Number: 3012447612-2022-00049
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-500360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Hispanic