MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.7MM SYSTEM EMERGENCY CROSS DRIVE SCREW; PLATE, BONE

Model Number N/A

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00566, 0001032347-2019-00567, 0001032347-2019-00568, 0001032347-2019-00569, 0001032347-2019-00570, 0001032347-2019-00571.Medical products: tmj system right standard mandibular component, part# 24-6545, lot# 535280d, 2.4mm system high torque (ht) cross-drive screw, part# 91-2708, lot# unk, 2.4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, 2.4mm system high torque (ht) cross-drive screw, part# 91-2712, lot# unk, traumaone system 2.0x9mm self-drilling imf screw, part# 91-5609, lot# unk, omnimax 24 gauge prestretch, part# 99-5824, lot# unk, 2.7mm system emergency cross drive screw, part# 99-9948, lot# unk.Occupation: patient.

Event Description

It was reported that patient will undergo a bilateral revision of temporomandibular implants at an unspecified future date due to an unknown reason.The prostheses will be replaced with a custom device.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.Three additional follow up attempts were made; however, no additional information was received.The patient did not state what led to the need for a revision surgery.The screws used in this case were not reviewed in the database due to their lot numbers being unknown.There are no indications of manufacturing defects.The most likely underlying cause cannot be determined.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.The following fields were updated: b4 date of this report b5 describe event or problem d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

Event Description

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

• Brand Name: 2.7MM SYSTEM EMERGENCY CROSS DRIVE SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9520316
• MDR Text Key: 178796540
• Report Number: 0001032347-2019-00572
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036058555
• UDI-Public: 00841036058555
• Combination Product (y/n): N
• PMA/PMN Number: K113512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: 99-9948
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention