MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIX PRE-BENT MAXILLARY PLATE/6MM ADVMNT/0.8MM THK/R; BONE PLATE

Model Number 04.511.385

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.(b)(4).Investigation summary: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed as devices were clearly broken into 2+ pieces.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2020, the patient underwent a revision of orthognathic surgery due to two broken maxillary plates.Initially, the patient underwent orthognathic double jaw surgery for sleep apnea in (b)(6) 2019 and after six months the surgery, the patient felt like his fixation weakened.The surgeon claims that patient "picked" at the hardware so that is what could have caused the failure.It was unknown if the revision surgery completed successfully.The patient outcome was unknown.This complaint involves eighteen (18) devices.This report involves one (1) ti matrix pre-bent maxillary plate/6mm advmnt/0.8mm thk/l.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.B3: updated event date to unknown.Updated procedure date: (b)(6) 2020.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI MATRIX PRE-BENT MAXILLARY PLATE/6MM ADVMNT/0.8MM THK/R
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11217095
• MDR Text Key: 228451375
• Report Number: 2939274-2021-00420
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587024271
• UDI-Public: 10887587024271
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.511.385
• Device Catalogue Number: 04.511.386
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Patient Sequence Number: 1
• Treatment: 1.85MM TI MATRIX SCREW SELF-DRILLING/6MM; 1.85MM TI MATRIX SCREW SELF-DRILLING/6MM; TI MTRX PRE-BNT MAXLRY PLT/6MM ADVNT/0.8MM THK/L; TI MTRX PRE-BNT MXILRY PLT/6MM ADVNT/0.8MM THK/L; TI MTRX PRE-BNT MXILRY PLT/6MM ADVNT/0.8MM THK/L
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR