MAUDE Adverse Event Report: BIOMET MICROFIXATION STERILETRAC SYSTEM X-DRIVE THINFLAP 2 HOLE STRAIGHT PLATE SET; BONE PLATE

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during incoming inspection it was identified the part number on the outer label is different than the part number on the patient label.The outer label is for catalog number 25-1005x, however the patient label is for catalog number 75-1030.There was no patient involvement.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The product identity was confirmed.The steriletrac system x-drive thinflap 2 hole straight plate set (part# 25-1005x, lot# 433030) was returned opened, with its original packaging.Visual evaluation of the product showed that the label on the outer non-sterile package showed a part# 25-1005x, lot# 433030, while the patient seal on the sterile package showed part# 75-1030, lot# 908100.The complaint is confirmed.The product in the package is part #25-1005x.Investigation results concluded that the reported event was due to human error during the packaging process.The incorrect patient seal was included in the package.There are no further indications of manufacturing defects.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned and no functional tests or inspections could be performed.The distributor provided a spreadsheet with pictures; however the complaint could not be verified due to the poor quality of the picture.For these reasons, the complaint could not be verified and the most likely underlying cause of the complaint could not be determined.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This report is being submitted to document the completion of the investigation.

• Brand Name: STERILETRAC SYSTEM X-DRIVE THINFLAP 2 HOLE STRAIGHT PLATE SET
• Type of Device: BONE PLATE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7519588
• MDR Text Key: 108866416
• Report Number: 0001032347-2018-00282
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: PK953385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• Device Expiration Date: 08/04/2022
• Device Model Number: N/A
• Device Catalogue Number: 25-1005X
• Device Lot Number: 433030
• Other Device ID Number: (01)00841036140359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1