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

Model Number N/A

Device Problem Retraction Problem (1536)

Patient Problems Discomfort (2330); Difficulty Chewing (2670)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation tmj system right narrow mandibular component catalog #: 01-6545 lot #: 584440d, biomet microfixation tmj system left narrow mandibular component catalog #: 01-6546 lot #: 550140d, biomet microfixation tmj system right fossa component, small catalog #: 24-6562 lot #: 651420a, biomet microfixation tmj system left fossa component, small catalog #: 24-6563 lot #: 682520b, biomet microfixation "2.4mm" system ht cross-drive screw catalog #: 91-2710 lot #: ni, biomet microfixation tmj system cross drive fossa screw catalog #: 99-6577 lot #: ni, biomet microfixation "2.7mm" system emergency cross drive screw catalog #: 99-9950 lot #: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, the devices remain implanted in the patient.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: 0001032347-2018-00239 through 0001032347-2018-00246.

Event Description

It was reported by the patient's father "issues have risen" and a replacement is being considered.Upon follow up it was reported her "surgeons are evaluating replacing her current jaw joints with two custom designed joints because she has had some retraction in the forward jaw movement.The angle of her mandible is still quite steep and her biting and chewing surfaces don¿t line up properly.The patient has said that occasionally she experiences some discomfort on the left side after chewing for more than a few minutes." no additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned and no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.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.Facial nerve dysfunction.It 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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00239-1 through 0001032347-2018-00246-1.

Event Description

Additional information was received.It was reported by the patient's mother that one surgeon recommended replacing the jaw joint with bigger, custom built joints.The patient also had a consultation with another surgeon, but have not yet followed up with him on his recommendations.For now, the patient's pain and discomfort are manageable so they are going to wait a bit and then re-evaluate the options.

• 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: 7488402
• MDR Text Key: 107450032
• Report Number: 0001032347-2018-00243
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 91-2708
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036053635
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention