MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.7X8MM HT X-DRIVE SCREW; CRANIOFACIAL BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number 91-2708

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

It was reported that the fossa prosthesis and mandibular component never fixed to the desired trajectory upon implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: tmj med rtfossa comp cat# 24-6560 lot# 7951900 45mm rt standard mandibular cat# 24-6545 lot# 829250c 2.7x8mm ht x-drive screw cat# 91-2708 lot# 325450 2.7x10mm ht x-drive screw cat# 91-2710 lot# 398050.(b)(6).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: 0001032347-2021-00517, 0001032347-2021-00518, 0001032347-2021-00519, 0001032347-2021-00520.

Manufacturer Narrative

The 2.7x8mm ht x-drive screw (item# 91-2708, lot# 325450) was returned for investigation.The screw appears to be bent/warped.This was checked by rolling it across a flat table.The screw showed signs of use, with damaged threads and wear on the head.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It is alleged that the devices were implanted incorrectly, however, without medical records a definitive root cause cannot be determined.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

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.

• Brand Name: 2.7X8MM HT X-DRIVE SCREW
• Type of Device: CRANIOFACIAL BONE SCREW, NON-BIOABSORBABLE, STERILE
• 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: 12770286
• MDR Text Key: 283421422
• Report Number: 0001032347-2021-00521
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00841036053635
• UDI-Public: (01)00841036053635(10)325450
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K001238
• 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,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 91-2708
• Device Lot Number: 325450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1