MAUDE Adverse Event Report: ZIMMER SPINE 6.5X45MM INSTINCT JAVA SCREW; INSTINCT JAVA SYSTEM

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference reports 3003853072-2021-00047.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.
Event or Problem Description
It was reported that two blockers and one screw broke while final tightening.When the first blocker broke a second blocker was used.This time both the blocker and the screw broke.Both the blocker and the screw were removed and new devices were inserted.There was no reported delay of surgery or impact on the patient.This is report one of three for this event.
Event or Problem Description
It was reported that two blockers and one screw broke while final tightening.When the first blocker broke a second blocker was used.This time both the blocker and the screw broke.Both the blocker and the screw were removed and new devices were inserted.There was no reported delay of surgery or impact on the patient.This is report three of three for this event.
Additional Manufacturer Narrative
Inspection the returned devices were examined.Visual inspection revealed a portion of one side of the pedicle screw's tulip has fractured off.One of the returned blockers has thread and drive mechanism damage.The other blocker is not damaged.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 zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during use.Device usage these devices are used for treatment.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.

• Brand Name: 6.5X45MM INSTINCT JAVA SCREW
• Common Device Name: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 11841813
• Report Number: 3003853072-2021-00049
• Device Sequence Number: 3425201
• Product Code: NKB
• UDI-Device Identifier: 00889024340282
• UDI-Public: (01)00889024340282(10)H36066(11)180515
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 046W0AN26545
• Device Lot Number: H36066A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1