MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEQUOIA TI POLYAXIAL SCREW ASSY 5.5MM X 40MM; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Catalog Number 3306-5540

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 pedicle screw disassembled during surgery.The tulip detached from the threaded shaft after the screw was final tightened, loosened, and re-tightened.The screw was removed and replaced with an alternative screw to complete the procedure.There were no reports of patient impacts associated with this event.

Manufacturer Narrative

The returned screw was evaluated.The tulip and swivel ring were confirmed to have disassembled from the screw shaft.The swivel ring was deformed in a manner consistent with either over-tightening or tightening and later loosening of the mating closure top and rod within the tulip.This deformation allows the tulip and swivel ring to disassemble from the screw shaft as the screw is manipulated during removal or reuse.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: SEQUOIA TI POLYAXIAL SCREW ASSY 5.5MM X 40MM
• 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
• 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: 6974009
• MDR Text Key: 90126368
• Report Number: 3012447612-2017-00567
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK131980
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3306-5540
• Device Lot Number: 85JA
• Other Device ID Number: (01)00889024334953(10)85JA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/24/2017
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1