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

Catalog Number	91-2708
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 2.7X8MM HT X-DRIVE SCREW
• Common Device Name: 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
• Report Number: 0001032347-2021-00521
• Device Sequence Number: 14534511
• Product Code: HWC
• UDI-Device Identifier: 00841036053635
• UDI-Public: (01)00841036053635(10)325450
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K001238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 01/21/2022; 03/21/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 02/14/2022; 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown