MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional 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, 0001032347-2019-00570, 0001032347-2019-00571, 0001032347-2019-00572.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 or Problem 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional 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.

• Brand Name: 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9520413
• Report Number: 0001032347-2019-00569
• Device Sequence Number: 3244470
• Product Code: JEY
• UDI-Device Identifier: 00841036053659
• UDI-Public: 00841036053659
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K001238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2712
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention