MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0X7MM SELF-DRILLING IMF SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Increased Sensitivity (2065); Limited Mobility Of The Implanted Joint (2671); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis as it remains implanted; 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: 0001032347-2020-00014, 0001032347-2020-00015, 0001032347-2020-00016, 0001032347-2020-00018.Medical products: tmj system right narrow mandibular component, part# 01-6550, lot# 541410c, tmj system right fossa component, small, part# 24-6562, lot# 561150a, 2.4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, traumaone system 2.0x7mm self-drilling imf screw, part# 91-5607, lot# unk, tmj system cross drive fossa screw, part# 99-6577, lot# unk.Occupation: patient.

Event Description

It was reported the patient may undergo a revision of temporomandibular joint implants on the right side at a later unspecified date due to an unknown reason.No additional patient consequences have been reported.

Event Description

This follow-up report is being submitted to relay additional information.The patient reported pain, sensitivity, limited range of motion and device squeaking.The patient reported that imaging reveals some degree of separation with the implant and that different surgeons have recommended replacement of the temporomandibular joint prostheses with either a custom implant or a bone graft.No revision is planned at this time.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following fields were updated: date of this report, describe event or problem, date received by manufacturer, type of report, follow up type, patient code, device code, additional narratives/data.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.The patient relocated and is looking for a new surgeon and the device remains implanted.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The screws involved in this case were not reviewed for non-conformances due to the lot numbers being unknown.There are no indications of manufacturing defects.The most likely underlying cause could not be determined.If any further information is found 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

This follow-up report is being submitted to relay additional information.

• Brand Name: TRAUMAONE SYSTEM 2.0X7MM SELF-DRILLING IMF SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9546679
• MDR Text Key: 174885047
• Report Number: 0001032347-2020-00017
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00841036128098
• UDI-Public: 00841036128098
• Combination Product (y/n): N
• PMA/PMN Number: K983728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-5607
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 02/20/2020; 05/21/2020
• Supplement Dates FDA Received: 03/12/2020; 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention