MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: MANDIBLE LOCKING; BONE PLATE

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this report is for an unk - screws: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the final splint did not fit very well on the maxilla (specifically the mesial cusps of the 13 & 14) and they were found to be more buccally positioned compared to the position indicated by the final splint.Fit on the mandible was not an issue and occlusion was adjusted by performing some occlusal grinding.Procedure was completed successfully with twenty(20) minutes delay.Concomitant device reported: unknown screw matrix mandible (part# unknown, lot# unknown, quantity unknown).This report is for one (1) unk: plates: mandible locking.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9, d10 h6: investigation summary: the device was not received.A manufacturing investigation was conducted by legal manufacturer: materialise based on the available product and patient information.Design review: the investigation performed concluded that the plate is not related to the complaint and has no impact on the issue.The issue is related to the splint design.Conclusion: during investigation, it was determined that the mandible plate was not implicated in this complaint condition and no issue was detected related to the plate; therefore the complaint is not confirmed.No definitive root cause could be attributed to this complaint condition.During the investigation, no product design was reviewed as not deemed necessary due to the product not being impacted.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 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: MANDIBLE LOCKING
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12118877
• MDR Text Key: 268092834
• Report Number: 8030965-2021-05520
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 08/13/2021
• Patient Sequence Number: 1
• Treatment: PS SPLINT ORTHOGNATHIC, FINAL.; PS SPLINT ORTHOGNATHIC, FINAL.; UNK - SCREWS: MATRIXMANDIBLE.; UNK - SCREWS: MATRIXMANDIBLE.