MAUDE Adverse Event Report: ZIMMER SPINE SEQUOIA SCREWDRIVER, MODULAR

Model Number 3363-1

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon evaluation of device.The information contained herein is being provided to the fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct.

Event Description

It was reported that the tip of a sequoia driver broke during insertion of a screw.The surgeon was using a sequoia driver to implant a sequoia screw into bone when an audible fracture was heard and the screw loosened on the driver.It was discovered that the tip of the driver had broken off.No surgical delay or patient impact was reported and the surgery was able to be completed with another device.Additional information has been requested but has not yet been received.

Manufacturer Narrative

As the device was not be returned for evaluation and despite multiple attempts for additional information and the device lot number, the information requested and the device were unavailable for investigation.Therefore, full analysis could not be performed.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.

• Brand Name: SEQUOIA SCREWDRIVER, MODULAR
• Type of Device: SEQUOIA SCREWDRIVER, MODULAR
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: rikke hanson ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5324948
• MDR Text Key: 34921236
• Report Number: 2184052-2015-00148
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

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: 3363-1
• Device Catalogue Number: 3363-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1