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

Catalog Number 046W1AN00650

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 3003853072-2017-00122.

Event Description

It was reported that the torque limiting handle did not work correctly during surgery and caused the final driver to break.An alternative final driver was used to complete the procedure.There were no reports of patient impacts associated with this event.This is report two of two for this event.

Manufacturer Narrative

The torque limiting handle was past its recalibration due date at the time of this event.However, the handle was not returned for evaluation so no results are available and no conclusions could be drawn.A review of the manufacturing records did not identify any issues which would have contributed to this event.

Manufacturer Narrative

Udi number: na.The returned handle was evaluated.The was tested and found to meet specifications.There were no device problems found.A review of the manufacturing records did not identify any issues which would have contributed to this event.

Event Description

It was reported that the torque limiting handle did not work correctly during surgery and caused the final driver to break.An alternative final driver was used to complete the procedure.There were no reports of patient impacts associated with this event.This is report two of two for this event.

• 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
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7159922
• MDR Text Key: 96611468
• Report Number: 3003853072-2017-00123
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 046W1AN00650
• Device Lot Number: ¿202310913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 02/27/2018; 12/17/2018
• Supplement Dates FDA Received: 03/07/2018; 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1