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

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3003853072-2021-00015 to 3003853072-2021-00021.

Event Description

It was reported that seven closure top threads stripped during an operation.Other plugs were used to complete the operation.There was no patient impact.This is report five of seven for this event.

Manufacturer Narrative

Device evaluation: visual inspection revealed that six of the seven returned devices have damaged threads, one of these also has drive mechanism damage.One of the seven has only drive mechanism damage.Potential cause: root cause was unable to be determined.This event could possibly be attributed to cross threading during use and off-axis forces applied during insertion.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.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 seven closure top threads stripped during an operation.Other plugs were used to complete the operation.There was no patient impact.This is report five of seven 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: 11398875
• MDR Text Key: 234497367
• Report Number: 3003853072-2021-00019
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024339910
• UDI-Public: (01)00889024339910(10)V16002760(11)161005
• 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
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 046W0AN00002
• Device Lot Number: V16002760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 72