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

Catalog Number 046W0AN00002

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

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 3003853072-2021-00098 through 3003853072-2021-00101.

Event Description

It was reported four java instinct blockers broke while final tightening into two different screws.The blockers were removed and replaced to complete the procedure without patient impacts.This is report two of four for this event.

Manufacturer Narrative

Corrected information in d4: lot number, d9, and h3.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.

Event Description

It was reported four java instinct blockers broke while final tightening into two different screws.The blockers were removed and replaced to complete the procedure without patient impacts.This is report two of four for this event.

Manufacturer Narrative

Device evaluation visual inspection revealed three of the four returned plugs have fractured threads and one of the plugs has damaged threads.Potential cause root cause was unable to be determined.This event could possibly be attributed to placing off-axis forces on the plug 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.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported four java instinct blockers broke while final tightening into two different screws.The blockers were removed and replaced to complete the procedure without patient impacts.This is report two of four 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
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12362141
• MDR Text Key: 267957469
• Report Number: 3003853072-2021-00099
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: V17083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/30/2021; 12/09/2021
• Supplement Dates FDA Received: 10/21/2021; 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1