MAUDE Adverse Event Report: ZIMMER BIOMET SPINE LINEUM COMPRESSOR

Catalog Number 14-525027

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

A functional test was not performed due to visual signs of a missing fastener.The cause of the missing fastener cannot be determined.A review of manufacturing records found no issues which would have contributed to this event.No further action is recommended at this time.

Event Description

The lineum compressor was returned with no information.Additional information was requested but not received.During device evaluation by zimmer biomet personnel, it was found that the instrument was missing a fastener; therefore the instrument can no longer be used per its intended use.

• Brand Name: LINEUM COMPRESSOR
• Type of Device: LINEUM COMPRESSOR
• Manufacturer (Section D): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: geoffrey gannon ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6491751
• MDR Text Key: 72795246
• Report Number: 3004485144-2017-00147
• Device Sequence Number: 1
• Product Code: HWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-525027
• Device Lot Number: 016630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• 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