MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL PEDICLE SCREW DIA.5,5 LG 45; INSTINCT JAVA SYSTEM

Catalog Number	046W0AN25545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
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 3003853072-2021-00113 through 3003853072-2021-00115.
Event or Problem Description
It was reported a revision surgery was performed to address 3 instinct java screws that fractured post-operatively.They were discovered after the patient presented with pain.A ct scan showed metallosis developed around the screws in addition to the breakage.This is report two of three for this event.
Event or Problem Description
It was reported a revision surgery was performed to address 3 instinct java screws that fractured post-operatively.They were discovered after the patient presented with pain.A ct scan showed metallosis developed around the screws in addition to the breakage.This is report two of three for this event.
Additional Manufacturer Narrative
Inspection: the products were not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review: the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimvie¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Device usage 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.

• Brand Name: POLYAXIAL PEDICLE SCREW DIA.5,5 LG 45
• 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: 12672123
• Report Number: 3003853072-2021-00114
• Device Sequence Number: 4233115
• Product Code: NKB
• UDI-Device Identifier: 00889024340237
• UDI-Public: (01)00889024340237(10)H29421B(11)160726
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 046W0AN25545
• Device Lot Number: H29421B
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown