MAUDE Adverse Event Report: MATERIALISE ANATOMICAL MODEL MANDIBLE - ORBIT, CLEAR; PLATE,FIXATION,BONE

Catalog Number SD900.206

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unk - plates : trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on an unknown date the plate was broken during the shipment.There was no involvement of surgery and patient.This complaint involves one (1) device.This report is for (1) unknown 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: d1, d2, d3, d4: updated.G1, g3, g5: updated.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.

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.Investigation summary: the investigation was performed by the legal manufacturer materialise.The complaint can be rated as confirmed as a picture of the broken bone model was provided in the received materialise report under their complaint reference c-med-20-5016, a copy of the report is attached at the complaint level.Result of the performed investigation by materialise: during the investigation, no issues with the packaging or production of the planned mandible model were found.The model was fine when it was shipped and was visually inspected.When reviewing the design a potential root cause for the breaking of the model was found.It was found that the connection bars between the mandible and posterior parts (rami) were not thick enough.Additionally, as the model can be considered weaker than usual (connection bars instead of solid mandible) a support bar should have been added between the rami.Nevertheless, the breakage still occurred during shipment.Therefore the courier is also a part of the root cause.A new model was built and sent to the sales rep.The bars connecting the posterior parts (rami) of the mandible and the mandible body (anterior part) should be designed with 7 mm thickness, not 6 mm.Additionally bar should be added in-between the rami to prevent flexibility.The engineers who designed and performed qi on the design were retrained ¿ see retraining in addendum of the materialse report.The courier ups was notified about this occurrence as transportation is also a part of the root cause.The identified issue is neither systemic nor systematic.No corrective/preventive action required and therefore no verification of effectiveness of the defined action required.Device history lot: the production documents were reviewed by the legal manufacturer and it can be confirmed that during the final visual inspection of the bone model (5b) no issues were found.The bone model was still intact and no issues were found.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.

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.H3, h4, h6- the investigation was performed by the legal manufacturer materialise.The complaint can be rated as confirmed as a picture of the broken bone model was provided in the received materialise report during the investigation, no issues with the packaging or production of the planned mandible model were found.The model was fine when it was shipped and was visually inspected.When reviewing the design a potential root cause for the breaking of the model was found.It was found that the connection bars between the mandible and posterior parts (rami) were not thick enough.Additionally, as the model can be considered weaker than usual (connection bars instead of solid mandible) a support bar should have been added between the rami.Nevertheless, the breakage still occurred during shipment.Therefore the courier is also a part of the root cause.A new model was built and sent to the sales rep.The bars connecting the posterior parts (rami) of the mandible and the mandible body (anterior part) should be designed with 7 mm thickness, not 6 mm.Additionally bar should be added in-between the rami to prevent flexibility.The engineers who designed and performed qi on the design were retrained ¿ see retraining in addendum of the materialse report.The courier ups was notified about this occurrence as transportation is also a part of the root cause.The identified issue is neither systemic nor systematic.No corrective/preventive action required and therefore no verification of effectiveness of the defined action required.Device history lot : the production documents were reviewed by the legal manufacturer and it can be confirmed that during the final visual inspection of the bone model (5b) no issues were found.The bone model was still intact and no issues were found.A dhr review was not performed for this pi.There are no records of this part or lot number ever having been manufactured by the monument facility.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: ANATOMICAL MODEL MANDIBLE - ORBIT, CLEAR
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): MATERIALISE; 44650 helm court; plymouth MI 48170
• MDR Report Key: 10213105
• MDR Text Key: 198402304
• Report Number: 8030965-2020-04567
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD900.206
• Device Lot Number: MU20NASNUL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1