MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 11MM; PLATE, BONE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Inflammation (1932)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint cmp (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2020-00619 medical products 6632799 left pm-tmj & model, part# tmjpm-3001, lot# 988040a unknown fossa screw, part# ni, lot# ni source ¿ (b)(6).

Event Description

It was reported that a revision was performed to remove a custom temporomandibular joint fossa component on the left side six (6) months following implantation due to screw loosening and screw fracture.During a follow up visit, the patient complained of a thick cheek and the ct scan showed that one (1) screw had fractured and one (1) screw had backed out of the fossa component.The patient was experiencing inflammation of the cheek and was being treated with anti-inflammatory drugs prior to the revision.In order to remove the fractured screw fragment, the surgeon had to drill some small holes around the end of the fractured screw fragment until he managed to grasp and twist out the piece with pliers.The surgeon noted that an unspecified number of remaining fossa screws were loose upon removal and the fossa component was loose.A new custom fossa component will be implanted at a future unspecified time.It was reported no further information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Five (5) screws were returned with one (1) fossa device.The item number(s) and lot number(s) of the returned screws were unknown.One of the five screws was fractured in the threaded portion of the screw.All five screws showed signs of use, as each had some discoloration and damage to the threads and cross-drive interface.It could not be determined which screw was the one that backed out.Part and lot identification are necessary for review of device history records, neither were provided.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.This report is being submitted to update additional information in section d9, h2, h3, h6 and h10.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Five (5) screws were returned with one (1) fossa device.The item number(s) and lot number(s) of the returned screws were previously unknown.One of the five screws was fractured in the threaded portion of the screw.All five screws showed signs of use, as each had some discoloration and damage to the threads and cross-drive interface.It could not be determined which screw was the one that backed out.Review of the device history records identified no deviations or anomalies during manufacturing.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.This report is being submitted to update additional information in section d1, d4, h2, h3, h6 and h10.D4 - there are four (4) potential lot numbers.Tmj system cross drive fossa screw 2.0mm x 11mm, part# 99-6581, lot# 939290, udi# (b)(4), manufacture date 19 dec 2018 tmj system cross drive fossa screw 2.0mm x 11mm, part# 99-6581, lot# 611790, udi# (b)(4), manufacture date 26 jun 2019 tmj system cross drive fossa screw 2.0mm x 11mm, part# 99-6581, lot# 796140, udi# ((b)(4) , manufacture date 20 nov 2019 tmj system cross drive fossa screw 2.0mm x 11mm, part# 99-6581, lot# 582290, udi# (b)(4), manufacture date 16 jan 2020.

Event Description

No further event information available at the time of this report.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 11MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11243119
• MDR Text Key: 229102327
• Report Number: 0001032347-2021-00031
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 99-6581
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention