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

Catalog Number 046W0AN00002

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

(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 3003853072-2020-00113, 3003853072-2020-00114, 3003853072-2020-00115, 3003853072-2020-00116.

Event Description

It was reported that the threads stripped on four java instinct blockers during an operation.The doctor used other blockers to complete the operation.There was no reported patient harm or injury.This is event four of four for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed for four returned blockers for the failure of stripped threads.Visual inspection of the items reveals threading damage on all four closure tops.Medical records were not provided for review.Potential cause the cause of the damage cannot be determined at this time since there is no information available regarding how the screw inserter was being used or handled at the time of the damage.However, it's possible that the damage to the blocker threads are consistent with cross-threading of the blockers into the screw tulip head during attempted installation.Complaint history a complaint search was conducted.Dhr review and related actions per dhrs review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this devices are used for treatment.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 the threads stripped on four java instinct blockers during an operation.The doctor used other blockers to complete the operation.There was no reported patient harm or injury.This is event four of four for this event.

• Brand Name: INSTINCT JAVA 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: 10848189
• MDR Text Key: 219158878
• Report Number: 3003853072-2020-00116
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024339910
• UDI-Public: (01)00889024339910(10)V17042(11)170823
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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: V17042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 67