MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4.0MM SOLID CANCELLOUS SCREW 30MM; PLATE, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product- plate 100 deg tubular 5 hole catalog#: 143555 lot#: 450850, 4.0 mm solid canc scr 30 mm catalog#: 1436930 lot#: sc3937, 3.5 cort bone screw 18 mm catalog#: 1437718 lot#: j3798154, 3.5 cort bone screw 18 mm catalog#: 1437718 lot#: j3798154.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08323, 0001825034-2018-08331, 0001825034-2018-08338, 0001825034-2018-08339.

Event Description

It was reported that the patient developed eczema caused by an allergic reaction following implantation of the trauma plate.Attempts have been made, however, no further information is available at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.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

No further event information available at the time of this report.

Manufacturer Narrative

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

• Brand Name: 4.0MM SOLID CANCELLOUS SCREW 30MM
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7798945
• MDR Text Key: 117653926
• Report Number: 0001825034-2018-08336
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1436930
• Device Lot Number: J-DMJ CD3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention