MAUDE Adverse Event Report: BIOMET MICROFIXATION UNK SCREW; PROSTHESIS, MICROFIXATION

Catalog Number UNK SCREW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Erosion (2075)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00302.Concomitant products: item# tmjpm-2870; lot# cp756446.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported that a patient underwent an initial surgery approximately one (1) year and three (3) months ago.Subsequently, the patient is indicated to be revised due to soft tissue erosion and intent to have less metal in the body.Patient has previously underwent radiation therapy.The implant is not objected by the surgeon.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided for the screws.A definitive root cause cannot be determined.It was reported that the patient developed soft tissue erosion, leading to the mandibular component being exposed.The implant is completely okay and is not objected by the surgeon.This could not be confirmed without medical records.The designer of the device, 3ds, was notified of the complaint and they conducted an investigation into the reported issue.For this case, the patient had an extended mandible designed on the left side.Review of the digital design files showed the 3ds designed aligned the segmented soft tissue from the ct scan data to the designed position of the maxilla and mandible to check the implant interference with pre-operative soft tissue data.This process was outside the 3ds design procedure for tmj.An image was provided which shows the implant is partially exposed through the surface of the patient's chin and in the inferior border area of the skin.This was not noted as a concern in the 3ds design phase or upon approval of the design.All process steps were found to be conforming to applicable specifications for design, inspection, and shipping.If any further information 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

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

• Brand Name: UNK SCREW
• Type of Device: PROSTHESIS, MICROFIXATION
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11869777
• MDR Text Key: 252297222
• Report Number: 0001032347-2021-00303
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2022
• 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: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male