MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. DORSAL HEIGHT AND REVISION TOOL; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Catalog Number 3367-2

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The piece of the hex socket at the tip of a dorsal height tool was found broken after surgery.There were no reported surgical impacts.

Manufacturer Narrative

Added information d3: email address, d8, h6: component codes, health effect-impact code, type of investigation, investigation findings, investigation conclusions corrected information in d9, h3 this follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for one (1) of one (1) returned sequoia revision tool (pn 3367-2) for the failure of fracture.Medical records were not provided for review.Device evaluation: visual inspection of 3367-2/61ha reveals that reveals that the tip is fractured.This complaint is confirmed.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 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.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

The piece of the hex socket at the tip of a dorsal height tool was found broken after surgery.There were no reported surgical impacts.

• Brand Name: DORSAL HEIGHT AND REVISION TOOL
• Type of Device: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10895997
• MDR Text Key: 218011033
• Report Number: 3012447612-2020-00676
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024335523
• UDI-Public: (01)00889024335523(10)61HA
• Combination Product (y/n): N
• PMA/PMN Number: K131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3367-2
• Device Lot Number: 61HA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1