MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5MM ROD,TI ALLY PRECUT CURVED-55MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02015.008

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3012447612-2017-00007.

Event Description

It was reported that the package label on two rods have information which differs from that on the rods themselves.The rods are marked as 50mm while the package labels state they are 55mm.There was no patient involvement with this event.This is report one of two for this event.

Manufacturer Narrative

The rod was not returned for evaluation; however, a photograph of the package label and device were provided.Investigation into the event utilizing other samples from this lot and a review of the manufacturing records determined that the length of the rod matched the part number etched on the rod, and also matched the part number and description on the package label.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 manufacturing error during the etching process.

• Brand Name: 5.5MM ROD,TI ALLY PRECUT CURVED-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: 6546006
• MDR Text Key: 74490531
• Report Number: 3012447612-2017-00006
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: N
• Patient Sequence Number: 1