MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ST360 RIGHT OFFSET CONNECTOR; ST360 DEGREES SPINAL FIXATION SYSTEM

Catalog Number 07.00297.001

Device Problem Disassembly (1168)

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

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.

Event Description

It was reported that a washer disassembled from an offset connector during surgery.An alternative offset connector was used to complete the procedure.There were no reports of patient injury associated with this event.

Manufacturer Narrative

The returned connector was evaluated.The device was found disassembled and one of the tines of the washer is bent into the center of the washer, preventing the tabs on the washer from securely engaging with the groove on the body of the connector.There is also a large area underneath the washer near the bent tine where the anodize has been scraped off.The cause of failure can most likely be attributed to attempting to tighten the connector while the screw is at an extreme angle.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: ST360 RIGHT OFFSET CONNECTOR
• 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: 6720017
• MDR Text Key: 80253378
• Report Number: 3012447612-2017-00322
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.00297.001
• Device Lot Number: 62897676
• Other Device ID Number: (01)00889024321892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2015
• 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