MAUDE Adverse Event Report: BIOMET MICROFIXATION STERILE TRAC THINFLAP 18.5MM BENT BURR PLATE; BONE PLATE

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint.(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 product in the package is a different part from what is listed on the label.The package contains catalog number 19-1020, but should contain catalog number 19-1020b.There was no patient involvement.

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: STERILE TRAC THINFLAP 18.5MM BENT BURR PLATE
• Type of Device: BONE PLATE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7519621
• MDR Text Key: 108902824
• Report Number: 0001032347-2018-00283
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K972322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

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: 10/09/2022
• Device Model Number: N/A
• Device Catalogue Number: SP-ST-1020B
• Device Lot Number: 319970
• Other Device ID Number: (01)00841036198251
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1