MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MM; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00081, 0001032347-2021-00082, 0001032347-2021-00473, 0001032347-2021-00474.Concomitant medical products: tmj system left fossa component, small, part# 24-6563, lot 531090a.Tmj system left standard offset mandibular component 45mm / 7 hole, part# 24-6646, lot# 461030a.2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot ni.2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot ni.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history records could not be reviewed as the lot numbers were unknown.A definitive root 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.

Event Description

It was reported the patient underwent a revision a couple years ago for an unknown reason following implantation of temporomandibular joint implants on the left side six (6) years ago.The patient is uncertain if the device remains implanted.Attempts have been made and no further information has been provided.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12669483
• MDR Text Key: 279631012
• Report Number: 0001032347-2021-00475
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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: 99-6577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention