MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 12/30/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product - zimmer biomet tmj system cross drive emergency fossa screw catalog #: 99-6589 lot #: 709700 qty: 1, zimmer biomet tmj system cross drive fossa screw catalog #: 99-6577 lot #: 636990 qty: 2, and zimmer biomet tmj system left fossa component medium catalog #: 24-6561 lot #: 013220d qty: 1.Report source: foreign - china.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00025, 0001032347-2023-00026, 0001032347-2023-00027, and 0001032347-2023-00029.

Event Description

It was reported that the screws loosened resulting in a revision surgery approximately 5 months post implantation.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned implants.The implants show signs of attempted use including marking/ scratching on both the fossa as well as the returned screws.All four returned screws show marking on the lower portion of the threads.A dimensional analysis was conducted on the returned qty (b)(4) 99-6589 lot 709700 screw as well as the qty (b)(4) 99-6577 lot 636990 screws.Feature a (overall screw length) and feature f3 (threaded major) were inspected on the screws.The screws meet these specifications.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.

Event Description

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

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW
• Type of Device: SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16239799
• MDR Text Key: 308075200
• Report Number: 0001032347-2023-00028
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036057442
• UDI-Public: (01)00841036057442(10)636990
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• 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: 99-6577
• Device Lot Number: 636990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2020
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Female