MAUDE Adverse Event Report: ZIMMER SPINE DYNESYS DTL SPACER CUTTER

Model Number 07.01284.001

Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

It was reported that a dynesys spacer cutter was found during kit inspection to be seized and stiff and hard to operate.

Manufacturer Narrative

Visual analysis of the returned device confirmed the reported event.Review of information provided and analysis of the returned device concluded that there is no evidence of a product defect.Manufacturing records reviewed indicated no deviations or anomalies.It is not suspected that the product failed to meet specifications.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.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.This submission does not constitute a determination or admission that a device has malfunctioned or that a device is related to a death or injury.

• Brand Name: DYNESYS DTL SPACER CUTTER
• Type of Device: DYNESYS DTL SPACER CUTTER
• 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: 5087052
• MDR Text Key: 26473707
• Report Number: 2184052-2015-00093
• Device Sequence Number: 1
• Product Code: NQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07.01284.001
• Device Catalogue Number: 07.01284.001
• Device Lot Number: 60970745A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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