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

Catalog Number	046W0AN00002
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional 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 3003853072-2021-00129 through 3003853072-2021-00134.
Event or Problem Description
It was reported that six blockers stripped during final tightening intra-operatively.They were removed and replaced to complete the procedure without patient impacts.This is report five of six for this event.
Event or Problem Description
It was reported that six blockers stripped during final tightening intra-operatively.They were removed and replaced to complete the procedure without patient impacts.This is report five of six for this event.
Additional 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.
Additional Manufacturer Narrative
Device evaluation; product was not returned and photos were not provided, so a device evaluation could not be completed.Potential cause root cause was unable to be determined.This event could possibly be attributed to cross threading or off-axis forces applied during plug 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 or Problem Description
It was reported that six blockers stripped during final tightening intra-operatively.They were removed and replaced to complete the procedure without patient impacts.This is report five of six for this event.

• Brand Name: BLOCKER
• Common Device Name: 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: 12831808
• Report Number: 3003853072-2021-00133
• Device Sequence Number: 4571372
• Product Code: NKB
• UDI-Device Identifier: 00889024339910
• UDI-Public: (01)00889024339910(10)E141562(11)170621
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 046W0AN00002
• Device Lot Number: E141562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 05/13/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/20/2021; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 66 KG