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

Catalog Number 046W0AN00002

Device Problem Fracture (1260)

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

Event Date 10/12/2020

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.Reference reports: 3003853072-2020-00109.

Event Description

It was reported that the threads of two blockers were stripped during surgery.They were both removed and replaced with alternative blockers to complete the procedure without reported patient impacts.This is report one of two for this event.

Event Description

It was reported that the threads of two blockers were stripped during surgery.They were both removed and replaced with alternative blockers to complete the procedure without reported patient impacts.This is report one of two for this event.

Manufacturer Narrative

Component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is confirmed for two instinct java blockers for the failure of stripped/damaged threads.This device is used for treatment.No medical records were provided with the complaint.Inspection the products were not returned for review, but photos were provided.When reviewing the photos, it appears that the threads on both blockers are damaged.The complaint is confirmed.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.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 of two blockers were stripped during surgery.They were both removed and replaced with alternative blockers to complete the procedure without reported patient impacts.This is report one of two for this event.

Manufacturer Narrative

The returned device was evaluated; visual inspection confirmed both devices have thread damage.There are no other changes from the prior investigation.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.

• 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: 10816981
• MDR Text Key: 215541439
• Report Number: 3003853072-2020-00108
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024339910
• UDI-Public: (01)00889024339910(10)V18129(11)190321
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: V18129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1