MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT; INSTINCT JAVA SYSTEM

Catalog Number	046W1AN00640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a warehouse found two final drivers both with fractured tips during inspection after they were returned from a hospital.The hospital did not provide any patient or surgical information with the returned devices.This is report one of two 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.Reference report 3003853072-2022-00007.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: visual inspection revealed that the tips of both drivers were fractured off.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 wear through use over time or multiple sterilization cycles.This event could also be attributed to off-axis forces applied during use.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that a warehouse found two final drivers both with fractured tips during inspection after they were returned from a hospital.The hospital did not provide any patient or surgical information with the returned devices.This is report one of two for this event.

• Brand Name: FINAL SCREWDRIVER SHAFT
• 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: 15310867
• Report Number: 3003853072-2022-00006
• Device Sequence Number: 6304496
• Product Code: NKB
• UDI-Device Identifier: 00889024342187
• UDI-Public: (01)00889024342187(10)A1432006A
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 046W1AN00640
• Device Lot Number: A1432006A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown