MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. DIA 5.5 PRECUT CURVED RODS, TI ALLOY 55MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02015.008

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2017

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.Reference reports 3012447612-2017-00129 and 3012447612-2017-00131 thru 3012447612-2017-00133.

Event Description

It was reported that four rods were found to be identified with the incorrect length while stocking them into sets.There was no patient involvement associated with this event.This is report one of four for this event.

Manufacturer Narrative

The returned rods were examined.Investigation into the event and a review of the manufacturing records determined that the actual length of the rod, the part number etched on the rod, and the part number and description (including length) on the package label were all correct.However, the length etched on the rod was incorrect; the length was etched as 50mm instead of the actual and correct length of 55mm.The cause is attributed to a supplier manufacturing error during the etching process.

• Brand Name: DIA 5.5 PRECUT CURVED RODS, TI ALLOY 55MM
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6603482
• MDR Text Key: 76394775
• Report Number: 3012447612-2017-00129
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.02015.008
• Device Lot Number: P142565
• Other Device ID Number: (01)00889024003965(10)P142565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1