MAUDE Adverse Event Report: ZIMMER SPINE BLOCKER; INSTINCT JAVA SYSTEM

Catalog Number 046W0AN00002

Device Problem Material Deformation (2976)

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

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Establishment name: (b)(6).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 3003853072-2020-00110.

Event Description

It was reported that during the surgery, two blockers stripped.A third blocker was successfully used.There were no impacts on the patient.This is report two of two for this event.

Manufacturer Narrative

Added information to h6: type of investigation, investigation findings, investigation conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for the failure of stripped/damaged threads.This device is used for treatment.No medical records were provided with the complaint.Inspection the identities of the returned devices match information in the complaint file.Visual inspection of the closure top reveals that both have fractured outer threads.Dhr review the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.It is possible that the blockers were cross-threaded into the mating pedicle screws during attempted installation.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that during the surgery, two blockers stripped.A third blocker was successfully used.There were no impacts on the patient.This is report two of two for this event.

• Brand Name: BLOCKER
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 10718671
• MDR Text Key: 212508947
• Report Number: 3003853072-2020-00111
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024339910
• UDI-Public: (01)00889024339910(10)V16002762(11)161010
• Combination Product (y/n): N
• PMA/PMN Number: K111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W0AN00002
• Device Lot Number: V16002762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 78