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

Catalog Number 046W0AN00002

Device Problem Material Deformation (2976)

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 one of ten for this event.

Manufacturer Narrative

The devices were returned and the part and lot information on the parts matched the information in the complaint file.Visual inspection found that all 8 closure tops had outer thread damage.Additionally, one of the closure tops had hex damage as well.The complaint is confirmed for 8 closure tops having outer thread damage and 1 closure top having hex damage.The device history record (dhr) was reviewed.There were no nonconformances or temporary deviations associated with this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.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.The reported complaint of the damage plug was confirmed.The exact cause of this event could not be determine with the available information.However, the drive mechanism damage is consistent with improper seating of the driver in the drive mechanism during torquing or axial forces applied during torquing.The thread damage is consistent with improper seating of the closure top in the screw head during torquing, resulting in cross-threading and thread damage.

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 one of ten for this event.

• 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
• MDR Report Key: 9510647
• MDR Text Key: 182794550
• Report Number: 3003853072-2019-00166
• 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: 09/02/2020

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: 046W0AN00002
• Device Lot Number: V17069
• 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: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR