MAUDE Adverse Event Report: ZIMMER SPINE FINAL SCREWDRIVER SHAFT; INSTINCT JAVA SYSTEM

Catalog Number 046W1AN00640

Device Problem Fracture (1260)

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

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 3003853072-2018-00116.

Event Description

It was reported that two final screw driver shafts were broken while final tightening the blocker during surgery.An alternative final screw driver was used to complete the procedure without reported patient impacts.This is report one of two for this event.

Manufacturer Narrative

Udi number: (b)(4).The driver was not returned so an evaluation was unable to be performed.Therefore, there are no results available and no conclusions can be drawn.A review of the manufacturing records did not identify any issues that would have contributed to this event.

Event Description

It was reported that two final screw driver shafts were broken while final tightening the blocker during surgery.An alternative final screw driver was used to complete the procedure without reported patient impacts.This is report one of two for this event.

Manufacturer Narrative

The returned device was examined.The tip was fractured and twisted.The complaint is confirmed.The cause is likely related to over-torquing or not being fully seated within the mating blocker during usage.

Event Description

It was reported that two final screw driver shafts were broken while final tightening the blocker during surgery.An alternative final screw driver was used to complete the procedure without reported patient impacts.This is report one of two for this event.

• Brand Name: FINAL SCREWDRIVER SHAFT
• 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: dorothee fleuri ; 23 parvis des chartrons; cite mondiale; bordeaux, cedex ; 33521905
• MDR Report Key: 8146959
• MDR Text Key: 130033382
• Report Number: 3003853072-2018-00115
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K111301
• 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,Followup,Followup
• Report Date: 08/26/2019

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 Catalogue Number: 046W1AN00640
• Device Lot Number: A2667303A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 03/28/2019; 07/29/2019
• Supplement Dates FDA Received: 04/24/2019; 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• 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