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

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

This device is not cleared in the us, but is similar to k111301.Device evaluation: visual investigation reveals that the inner hexes on four of the blockers were stripped.Functional investigation using mating parts showed that the blockers with damaged threads were non-functional because they could not fully engage the blocker holder.Potential cause: root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during tightening.Dhr review and related actions: per the 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.Device use: this device is used for treatment.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 3003853072-2021-00005 thru 3003853072-2021-00008.

Event Description

It was reported that the hex on five blockers were stripped during installation within surgery.However, device evaluation by the manufacturer found that the threads on four of the blockers were stripped.The blockers were removed and replaced during the surgery without patient impact.This is report three of four for this event.

• Brand Name: BLOCKER
• Type of Device: SIMILAR TO 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 11346102
• MDR Text Key: 232586786
• Report Number: 3003853072-2021-00007
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 03700456000155
• UDI-Public: (01)03700456000155(10)E89815(11)151105
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: SEE H10
• 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
• Report Date: 02/18/2021

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 Model Number: N/A
• Device Catalogue Number: SN2023-0-00002
• Device Lot Number: E89815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 77