MAUDE Adverse Event Report: ZIMMER SPINE STRAIGHT ROD DIA. 5.5 LG 400; INSTINCT JAVA SYSTEM

Catalog Number	046W0AN50400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report replaces 3012447612-2022-00214.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 report 3003853072-2022-00009.
Event or Problem Description
The patient presented with pain and rod and screw breakage so a revision surgery is planned to replace the rod and additional screws.The specific identity of the implants that broke will not be available until after the revision.This is report one of two for this event.
Event or Problem Description
The patient presented with pain and rod and screw breakage so a revision surgery is planned to replace the rod and additional screws.The specific identity of the implants that broke will not be available until after the revision.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in d6a.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and x-rays were not provided.Device evaluation could not be performed.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown surgical, patient or post-op traumatic factors.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.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: STRAIGHT ROD DIA. 5.5 LG 400
• 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: 15513974
• Report Number: 3003853072-2022-00008
• Device Sequence Number: 5856124
• Product Code: NKB
• UDI-Device Identifier: 00889024341326
• UDI-Public: (01)00889024341326(10)E86736(11)160622
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 046W0AN50400
• Device Lot Number: E86736
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2016
• 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: Required Intervention; Hospitalization
• Patient Sex: Male