MAUDE Adverse Event Report: ZIMMER SPINE REDUCTION POLYAXIAL PEDICLE SCREW DIA.6.5 LG 40; INSTINCT JAVA SYSTEM

Catalog Number	046W0AN46540
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
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 3003853072-2021-00110 through.
Event or Problem Description
It was reported that during the surgery, a closure top and a screw stripped intra-operatively.Also, a second closure top stripped on the same screw.All pieces were removed and replaced with alternatives to complete the procedure.There were no reported patient impacts.This is report three of three for this event.
Event or Problem Description
It was reported that during the surgery, a closure top and a screw stripped intra-operatively.Also, a second closure top stripped on the same screw.All pieces were removed and replaced with alternatives to complete the procedure.There were no reported patient impacts.This is report three of three for this event.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed that both closure tops had heavily damaged threads with parts of the threads fractured off.The tulip head of the screw had some visible damage to the threading.Potential cause root cause was unable to be determined.This event could possibly be attributed to inserting the closure tops off-axis and cross threading them.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.Device use: these devices are 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.

• Brand Name: REDUCTION POLYAXIAL PEDICLE SCREW DIA.6.5 LG 40
• 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: 12672113
• Report Number: 3003853072-2021-00112
• Device Sequence Number: 14511373
• Product Code: NKB
• UDI-Device Identifier: 00889024341081
• UDI-Public: (01)00889024341081(10)H30094IR(11)180427
• 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
• Report Date (Section B): 04/22/2022

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: 046W0AN46540
• Device Lot Number: H30094IR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2018
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 56 KG