MAUDE Adverse Event Report: SYNTHES GMBH UNK - PSI IMPLANTS; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Device Problem Break (1069)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown psi implant/unknown lot.Part and lot number are unknown; udi number is unknown.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

Device report from (b)(6) reports an event as follows: it was reported that on unknown date during a surgery a splint cracked at the molar region while being used.The patient came back, the occlusion and everything else was good.The splint cracked while they were trying to put the teeth in and the part came off completely.This report is for one (1) unknown psi implant.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.Dhr was performed and the device met specifications.The two nc were identified in the dhr but are not related to this complaint condition.Investigation summary: the device was not received.A manufacturing investigation was conducted by the legal manufacturer based on the available product and patient information.Design review: since this issue is related to mechanical integrity, therefore the design of the splint, the planning, splint design, and production steps will be investigated.During the investigation, the steps which could influence the strength of the splint were reviewed.No issues were found with the design of the guide.The splint did break on the weakest location based on thickness analysis, but the splint still met the specifications.The weaker and stronger parts of the splint depend on the occlusion and planning determined by the surgeon.The production process did not reveal any issues as all steps were done correctly.It could be that the splint already got damaged slightly during post-processing or shipment but this cannot be confirmed.The proposed action was considered and a capa was initiated.Further investigation will be done in the capa.Conclusion: the complaint condition could be confirmed.The possible root cause could be that the splint already got damaged slightly during post-processing or shipment but this cannot be confirmed.Since there were multiple splint breakages, the legal manufacturer initiated a capa and further investigation will be done.Additionally, johnson & johnson has initiated the nc to track the capa.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

The procedure was successfully completed.The patient was reported as good.

• Brand Name: UNK - PSI IMPLANTS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12319085
• MDR Text Key: 266703363
• Report Number: 8030965-2021-06647
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 10/13/2021
• Patient Sequence Number: 1