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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that the final screwdriver tip fractured while tightening the blocker.The tip was retrieved and the surgery was completed using another driver.There was no impact on the patient.

Event Description

It was reported that the final screwdriver tip fractured while tightening the blocker.The tip was retrieved and the surgery was completed using another driver.There was no impact on the patient.

Manufacturer Narrative

Added information to d8, h6: component codes, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for one (1) of one (1) returned instinct java screw driver (pn 046w1an00641) for the failure of tip fracture.Medical records were not provided for review.Device evaluation: visual inspection revealed the tip of the device has fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to off-axis forces exerted on the device during use.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.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: FINAL SCREWDRIVER SHAFT II
• 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: 11304949
• MDR Text Key: 232351158
• Report Number: 3003853072-2021-00002
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 0089024342194
• UDI-Public: (01)0089024342194(10)A2326708A(11)160428
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

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: 046W1AN00641
• Device Lot Number: A2326708A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 75