MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5MM X 40MM UNIPLANER SCREW; POLARIS SPINAL SYSTEM

Catalog Number 14-512340

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation: the part was discarded by the hospital but the pictures provided show the screw being fractures in the middle of the shaft.The complaint is confirmed.Complaint history: there were zero (0) other complaints for similar events (post-op screw fracture) related to the same part number in the 12 months leading up to the notification date through to the present.Zero (0) additional search results for the lot and item search.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.Potential cause: this event could possibly be attributed unintended motion of patient post operation, which might have caused the screw to fracture.With the given information, the definitive cause cannot be determined.

Event Description

It was reported that a revision was performed to address a screw at bottom of scoliosis construct that broke mid shaft (in pedicle).The rods were cut bilaterally and the bottom screws were removed bilaterally.No new implants were used.

• Brand Name: 5.5MM X 40MM UNIPLANER SCREW
• Type of Device: POLARIS SPINAL SYSTEM
• 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: jessica buzbee ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3038034523
• MDR Report Key: 11016347
• MDR Text Key: 221737436
• Report Number: 3012447612-2020-00675
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-512340
• Device Lot Number: 2368691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 15 YR