MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 7.0MMX27.5MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211H7027

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Event Description

It was reported that a tether set screw did not fit with the mating screw intra-operatively.The set screw was removed and replaced to complete the procedure without patient impacts.Device evaluation buy the manufacturer found the set screw was stripped.

Manufacturer Narrative

Procode: qhp.Device evaluation: visual inspection revealed that the set screw lead thread was bent in a manner consistent with cross-threading.Functional testing confirmed that the set screw would not seat in the tulip head.Potential cause: root cause was unable to be determined.This event could possibly be attributed to cross threading.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: SCREW+SS 7.0MMX27.5MM
• Type of Device: THE TETHER - VERTEBRAL BODY TETHERING 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13690733
• MDR Text Key: 289320694
• Report Number: 3012447612-2022-00058
• Device Sequence Number: 1
• Product Code: QHP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: H190005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211H7027
• Device Lot Number: 3020073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2020
• 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