MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ST360 MINI STRAIGHT CONNECTOR 10-12MM; ST360 DEGREES SPINAL FIXATION SYSTEM

Catalog Number 07.00295.004

Device Problem Disassembly (1168)

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

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that a connector disassembled when it was being assembled with the rod during surgery.It was removed and replaced with an alternative connector.There was no patient impact reported as a result of this event.

Manufacturer Narrative

The returned connector was evaluated.The washer was found disassembled from the body of the connector and the lip of the washer was found to be bent.The cause cannot be definitively determined.A review of the manufacturing records did not identify any issues which may have contributed to this event.

• Brand Name: ST360 MINI STRAIGHT CONNECTOR 10-12MM
• 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: 6829750
• MDR Text Key: 83962586
• Report Number: 3012447612-2017-00429
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK133291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.00295.004
• Device Lot Number: 63376571
• Other Device ID Number: (01)00889024321854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2016
• 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