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	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was examined.The tip was found to be fractured.Previous failures of this nature have been attributed to a concentration of stresses due to improper seating an/or off-axis forces.The complaint is confirmed.There were no manufacturing issues detected which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding device usage.
Event or Problem Description
It was reported that during the procedure the tip of the driver twisted.No further surgical information was provided and no reported patient impacts.However, device evaluation by zimmer biomet personnel found the tip of the driver to be fractured.

• 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
• MDR Report Key: 10171489
• Report Number: 3003853072-2020-00047
• Device Sequence Number: 2152424
• Product Code: NKB
• UDI-Device Identifier: 00889024342187
• UDI-Public: (01)00889024342187(10)A2696203A(11)180613
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K111301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: A2696203A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1