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 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Udi#: (b)(4).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 3003853072-2020-00099 to 3003853072-2020-00102.

Event Description

It was reported that during surgery, the surgeon was reviewing the c-arm image and decided he needed to adjust the angle of the screw.When he attempted to remove the screw, the tips of two final drivers broke, the broken tips were retrieved the blocker stripped in the tulip head and the screw could not be pulled out.It was reported that the torsion force of t-handle is too large, which leads to the fracture of screwdriver.There was an approximate 20 minute delay and competitor product was used to complete the case.There were no reported patient impacts.This is report 4 of 4 for this event.

Manufacturer Narrative

E1: establishment name: (b)(6) hospital.This follow-up report is being submitted to relay additional information and initially corrected information added information to e1: establishment name.Summary: the complaint is confirmed for the returned instinct java blocker (pn 046w1an00002) for the failure of jamming in the screw and having hex damage due to difficulty removing.Medical records were not provided for review.Device evaluation: functional testing of the closure top-screw complex using screwdriver shaft 046w1an00640/a1541708a reveals that the closure top was unable to be loosened.Potential cause root cause was unable to be determined.The blocker was likely over-tightened due to the tld being out of calibration.The overtightening could have lead to the force required to remove the blocker being higher than the force that the material of the blocker and drivers could handle, thus damaging both.It is also possible off-axis forces were applied to the blocker, causing to cross-thread and jam in the screw, causing the hex drive to deform or causing the tips of the drivers to break.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference reports 3003853072-2020-00099 to 3003853072-2020-00102.

Event Description

It was reported that during surgery, the surgeon was reviewing the c-arm image and decided he needed to adjust the angle of the screw.When he attempted to remove the screw, the tips of two final drivers broke, the broken tips were retrieved.The blocker stripped in the tulip head and the screw could not be pulled out.It was reported that the torsion force of t-handle is too large, which leads to the fracture of screwdriver.There was an approximate 20 minute delay and competitor product was used to complete the case.There were no reported patient impacts.This is report 4 of 4 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: 10503280
• MDR Text Key: 206000180
• Report Number: 3003853072-2020-00102
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• 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: V17042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 66