MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN SCREW

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Numbness (2415)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(64.D10: medical product - zimmer biomet walker right pm-tmj & model catalog #: tmjpm-1627 lot #: 743210, zimmer biomet unknown screw catalog #: unknown lot #: unknown g2: united kingdom 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.

Event Description

It was reported that a revision is planned due to two screws near the facial nerve causing pain and numbness in the lip as well as the fossa being positioned too close to the ear canal causing pain.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h6 and h10.Correction is in section a2.

Event Description

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

Event Description

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

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.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The designer of this device, 3d systems, was notified of this complaint and an investigation was conducted.Review of the device's dhr showed that there were no issues with the plan or design.The pre-operative scans for the planned replacement device tmjpm were used as the post-operative scans for initial tmjpm to compare the placement of the fossa compared to the plan.Digital review of the implant and patient anatomy for tmjpm initial implant revealed the fossa was improperly placed.The design plan included adequate space from the tympanic plate and ear canal.Scans used for the design of the second tmjpm reveals that the implant was placed too far posterior, resulting in the implant contacting the tympanic plate.Review of the digital files also showed that the mandibular implant was not placed according to plan.The most distal hole leaves adequate space from the hole to the nerve.However, the actual placement of the implant results in the screw contacting the facial nerve.A comparison was made between the original design images and the scans taken approximately 6 years later for designing a new replacement device, it could not be definitively concluded that the original placement of the device is the reason for the reported event.The reported event is confirmed, based on the investigation report provided by 3d systems.If any further information is found that 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 sections b4, b5, g3, g6, h2, h3, h6, and h10.

• Brand Name: UNKNOWN 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: 18047252
• MDR Text Key: 327079123
• Report Number: 0001032347-2023-00405
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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: UNKNOWN SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 02/29/2024
• Supplement Dates FDA Received: 12/27/2023; 03/08/2024
• 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: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Female