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 10/20/2020

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 reports: 3003853072-2020-00117, 3003853072-2020-00118, and 3003853072-2020-00119.

Event Description

It was reported that four instinct java plugs stripped their threads during an operation.The doctor used other plugs complete the operation, and there was no reported patient harm, or injury, however, the surgery was delayed for 10 minutes.This is report four of four for this event.

Manufacturer Narrative

Added information to h6: component, type of investigation, investigation findings, and investigation conclusions.Corrected information in d9 and h3.This follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for the returned instinct java blockers (pn: 046w0an00002) for the failure of deformation.Visual inspection revealed all four returned devices have hex/drive mechanism damage and outer thread damage.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 blockers were being used or handled at the time of the damage.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions are required.This event is not related to any current actions or recalls or product holds.Device use this device is 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 four instinct java plugs stripped their threads during an operation.The doctor used other plugs complete the operation, and there was no reported patient harm or injury; however, the surgery was delayed for 10 minutes.This is report 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: 10863264
• MDR Text Key: 217672391
• Report Number: 3003853072-2020-00120
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 03700456035027
• UDI-Public: (01)03700456035027(10)E83340(11)141224
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: E83340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 66