MAUDE Adverse Event Report: ZIMMER SPINE TORQUE LIMITING T-HANDLE; INSTINCT JAVA SYSTEM

Catalog Number 046W1AN00650

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2019

Event Type  malfunction  

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 reports 3003853072-2019-00166 to 3003853072-2019-00175.

Event Description

It was reported that during the procedure the threads of eight plugs were damaged, the torque handle was out of specification, and the tip of the driver fractured.The tip was removed and the case was completed using an alternate driver and closure tops.There were no patient impacts reported.This is report three of ten for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi#: (b)(4).Catalog#: 046w1an00641 final scrdrv shaft rigid ij lot#: a2447214a.Catalog#: 046w0an00002 instinct java blocker lot#: v17069 qty: 8.The event is confirmed with product received.The torque was found to be between 12.44 nm and 14.31 nm with an average of 13.28 nm, which is more than the maximum 11nm.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: TORQUE LIMITING T-HANDLE
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 9510660
• MDR Text Key: 182799154
• Report Number: 3003853072-2019-00168
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W1AN00650
• Device Lot Number: A200673402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Age: 66 YR