MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PSI IMPLANTS; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Device Problem Break (1069)

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

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

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.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

It was reported that on an unknown date, there was an issue with the splints.The wiring holes on the final splint were too far off from the brackets; they broke off the brackets.The sandwich style was used for the splints.In the case, the splint was burred down and new wiring holes were placed.The procedure was completed with minimal delay and with no issues or harm to the patient.This report is for a splint.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.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

There was no injury to the patient.No delay in surgery.No, revision surgery is needed.The breaking of the brackets occurred when one of the braces were pulled away from the patients braces on their teeth and was replaced in surgery.

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.H6: investigation summary: the device was not received.A manufacturing investigation was conducted by the legal manufacturer: materialise based on the available product and patient information.Design review: during the investigation, it was found that the issue is limited to the position of the wiring holes as they were planned, so there is no need to investigate the images, segmentation, or production step.Only the planning and guide/splint design step need to be reviewed.The position of the wiring holes in the splint was reviewed.The design of the splint was done correctly and according to the work instructions.However, the planning and more specifically the position of the mandible and maxilla in the intermediate position in combination with the sandwich splint caused the wiring holes to be further from the teeth than preferred in the final position.This could have been prevented as wiring holes were not needed in the intermediate splint.Only the final splint was intended to be wired in but due to lack of communication between surgeon and cle it could have lead to the complaint condition.Conclusion: the complaint condition could be confirmed for the complaint device.No definitive root caused could be determined.However the lack of appropriate communication between user and cle could have cause the complaint condition.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted.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.Dhr: part number: sd900.105, lot#: mu21-sim-gax, dhr was performed by materialise and the device met specifications.There was no nc identified in the dhr of this case.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 - PSI IMPLANTS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12276937
• MDR Text Key: 265478932
• Report Number: 2939274-2021-04480
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1