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

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 reports 3012447612-2018-00767, 3012447612-2018-00769, and 3012447612-2018-00770.

Event Description

It was reported that three rods were found to be identified with the incorrect length during a check.There was no patient involvement associated with this event.This is report three of three for this event.

Manufacturer Narrative

Additional information: (method, results, conclusions) - the returned rod was evaluated.A review of the manufacturing records determined that the length of the rod matched the part number laser marked on the rod, and also matched the part number and description on the package label; however, the length marked on the rod is incorrect.It was marked as 50mm instead of the correct length of 55mm.The cause is attributed to a manufacturing error during the laser marking process.

Event Description

It was reported that three rods were found to be identified with the incorrect length during a check.There was no patient involvement associated with this event.This is report three of three for this event.

• 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7890791
• MDR Text Key: 120832209
• Report Number: 3012447612-2018-00770
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 07.02015.008
• Device Lot Number: P142565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2018
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1