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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation tmj system left narrow mandibular component catalog #: 01-6546 lot #: 666080a, biomet microfixation "2.4mm" system ht cross-drive screw catalog #: 91-2712 lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2018-00286 and 0001032347-2018-00287.

Event Description

It was reported a revision was performed due to the left tmj prosthesis being too posterior in the fossa, therefore it needed to be advanced to improve function and decrease pain.Only the mandibular component was removed in the revision.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.These parts were removed in a revision; therefore the complaint is considered confirmed.No product was returned and no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.For aforementioned reasons, the most likely underlying cause of this complaint cannot be determined.However, the statement that appeared to be an excerpt from the patient's medical record suggests that the positioning and alignment of the implants was a contributing factor to the complaint.Device history record (dhr) was reviewed for the mandibular component and no discrepancies were found.Device history record (dhr) review was unable to be performed for the screws as the lot number of the device involved in the event is unknown.The instructions for use (ifu) for this product warns of the potential for complications.It states in the section titled adverse events: facial swelling and/or pain.The ifu also states in the section titled patient counseling information: discussion of the following points is recommended prior to surgery.The risks associated with a total tmj system (see warnings and adverse events).Post-operative pain relief and return of function varies from patient to patient.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00286-1 and 0001032347-2018-00287-1.

Event Description

This report is being submitted to document the completion of the investigation.

• Brand Name: "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7526902
• MDR Text Key: 108723066
• Report Number: 0001032347-2018-00285
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: PK001238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: N/A
• Device Catalogue Number: 91-2710
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036053642
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR