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

Catalog Number	046W1AN00641
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2022
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.
Event or Problem Description
It was reported that one instinct final driver was returned from a hospital with the tip fractured off; the tip was not returned.The specific surgical or patient information is unknown.
Event or Problem Description
It was reported that one instinct final driver was returned from a hospital with the tip fractured off; the tip was not returned.The specific surgical or patient information is unknown.
Additional Manufacturer Narrative
Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed the tip is fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to off-axis forces exerted on the device during use.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: FINAL SCREWDRIVER SHAFT II
• 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: 13686237
• Report Number: 3003853072-2022-00001
• Device Sequence Number: 1905659
• Product Code: NKB
• UDI-Device Identifier: 00889024342194
• UDI-Public: (01)00889024342194(10)A2524718A(17)171012
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 046W1AN00641
• Device Lot Number: A2524718A
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2017
• 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