MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ST360 STRAIGHT CONNECTOR, 10MM ¿ 15MM; ST360 DEGREES SPINAL FIXATION SYSTEM

Catalog Number 07.00295.001

Device Problem Disassembly (1168)

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

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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 3012447612-2018-00073.

Event Description

It was reported that two connectors disassembled while being installed with the mating rods during surgery.The connectors were removed and replaced with alternative connectors.There were no reports of patient impacts associated with this event.This is report one of two for this event.

Manufacturer Narrative

Udi number: (b)(4).The device was not returned for evaluation, however, a photo was provided and used for evaluation.It was found that the washer has detached from the connector.It is possible that the device component may have loosened after repeated cleaning/sterilization/general handling over time; however, the device was not returned, so a formal evaluation is unable to be performed.A review of the dhr did not find any issues which would have contributed to this event.

• Brand Name: ST360 STRAIGHT CONNECTOR, 10MM ¿ 15MM
• Type of Device: ST360 DEGREES SPINAL FIXATION 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7192392
• MDR Text Key: 97752136
• Report Number: 3012447612-2018-00067
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK133291
• 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,Followup
• Report Date: 09/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.00295.001
• Device Lot Number: 63206406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1