MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL 3.5 SCREWDRIVER UNIVERSAL; INSTINCT JAVA SYSTEM

Catalog Number 046W1AN00555

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/27/2017

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 report 3003853072-2017-00121.

Event Description

It was reported that two screwdrivers would not hold a pedicle screw rigid during the surgery.The surgeon held the distal end of the screw with his hand while installing it to ensure it was installed at the proper trajectory and location.There were no reports of patient impacts associated with this event.This is report one of two for this event.

Manufacturer Narrative

The screw driver was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions for use.

• Brand Name: POLYAXIAL 3.5 SCREWDRIVER UNIVERSAL
• 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: 7159898
• MDR Text Key: 96458574
• Report Number: 3003853072-2017-00120
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W1AN00555
• Device Lot Number: A20498003A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• 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