MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: CMF; PLATE, BONE

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown cmf plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

Device report from (b)(6) reports an event as follows: it was reported that the models had half a tooth left which sat directly superior to the mandible resections.This meant that the team were not able to accurately use the planned model to see if the plated fibula graft sections would fit; the half tooth, bilaterally, on the model was in the way, and entire teeth are removed during the mandible resection.This report is for an unknown cmf plate.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.H10 additional narrative: h3, h4, h6- the device was not received.A manufacturing investigation was conducted by legal manufacturer: materialise based on the available product and patient information.Design review: during the investigation, the planning and design of the guide/models were reviewed.The models were designed correctly and match the planning, which the surgeon approved.The vertical mandible cut is not guided and was done according to the planning.The surgeon is responsible for decision on the removal of teeth and the way they choose to continue with the mandible cut.Hence, no problems were detected with the planning and design of the models and guide.The complaint condition cannot be confirmed.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: the part/lot no is unknown.No mre performed.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: UNK - PLATES: CMF
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12103633
• MDR Text Key: 259716385
• Report Number: 8030965-2021-05497
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Patient Sequence Number: 1