MAUDE Adverse Event Report: ZIMMER SPINE BLOCKER; INSTINCT JAVA SYSTEM

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 11/15/2016

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.This is report one of two for this event.Reference report 3003853072-2016-00158.

Event Description

It was reported that the threads were damaged on two blockers during final tightening.They blockers were removed and replaced.There were no reports of patient injury associated with this event.

Manufacturer Narrative

Udi number: (b)(4).The returned blocker was evaluated.The threads were confirmed to be deformed and the cause was determined to be cross-threading due to misalignment of the blocker with the mating screw.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 regarding proper device usage.

• Brand Name: BLOCKER
• 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 ; 310 interlocken pkwy ste. 120; broomfield 80021 ; 3034437500
• MDR Report Key: 6180760
• MDR Text Key: 62619266
• Report Number: 3003853072-2016-00159
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 046W0AN00002
• Device Lot Number: E86280
• Other Device ID Number: (01)00889024339910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1