MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL SCREW 5.5 X 40; PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

Catalog Number 3505-5540

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

The device was scrapped by the hospital, so it is not available for evaluation.A review of the manufacturing records did not identify any issues which would have contributed to this event.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 3012447612-2017-00216.

Event Description

It was reported that the tulips of two pedicle screws disassembled during surgery.After placing the closure tops, the surgeon decided to remove the closure tops so that the rod could be further contoured.After the rod was removed, the surgeon found two of the tulips had disassembled from their screw shafts and proceeded to remove the screw shafts which led to a delay of 100 minutes.Two additional screws were installed to complete the procedure.This is report one of two for this event.

Manufacturer Narrative

Although the device was not returned for evaluation, a photo was provided and was used for evaluation purposes.It appears that at least one of the three splines on the screw shaft has been deformed, which allows the screw tulip to disassemble from the screw shaft.The cause is likely attributed to tightening and then loosening the closure top within the screw tulip.

• Brand Name: CANNULATED POLYAXIAL SCREW 5.5 X 40
• Type of Device: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW 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: 6650590
• MDR Text Key: 77866962
• Report Number: 3012447612-2017-00215
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK132884
• 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: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3505-5540
• Device Lot Number: 87ND
• Other Device ID Number: (01)00889024335622(10)87ND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR