MAUDE Adverse Event Report: SYNTHES GMBH PSI 160*100*40 PEEK; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.436

Device Problem Defective Device (2588)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the psi peek implant edge did not sit flush and the overall curvature was too convex.The surgeon experienced difficulty fitting the implant to close the wound during an unknown procedure.The procedure outcome is unknown.Patient outcome is unknown.There is no further information available.This report is for one (1) psi 160*100*40 peek.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Event occurred on an unknown date in 2021.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.

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 - codes updated to imdrf codes.The device was not received.The photo was received under pc attachment "peek cranioplasty post op.Jpg".A product development investigation was conducted by r&d team based on the available product/image and patient information.Reference pi attachment "(b)(4) - complaint investigation_signed.Pdf" for complete investigation, which is summarized below.Design review: an investigation was conducted into the device design to determine if the design contributed or caused the issues as described in the complaint description.With the complaint one (1) intra-operative image which shows the patient situation was received.The surgeon confirmed the following design features for this psi device on 01 july 2021 temporal cut (location defined with provided image from surgeon) no predrilling holes for the full flap section the main body of both psi will be designed with a thickness of 4mm.A full flap around the psi, as per the image 1 below, with a material thickness of 1.5mm and a maximum extent of about 5mm.Offset from 1mm (standard offset is 0.2mm) were confirmed on 01 july 2021 the design review of the patient scan data received and that of the final psi device resulted that the psi device fits and match the patient situation and no mismatch could be identified.All requested features and changes were implemented in that finial design.The review of the design for the implant was created according to the relevant work instruction for psi design (w-c-s030).The review of the case file ¿patient specific implant design review checklist¿ for this implant showed that the implant was reviewed and approved by an independent reviewer according to the relevant work instruction for psi design (se_039100_aa).Conclusion: the complaint condition cannot be confirmed for the device.Per the investigation description above, the psi case files, communication, design feature request, intraoperative image and post-operative scan data were reviewed.The investigation included a review of the documentation and forms along with the surgeon complaint report.The design of the device was completed and verified as per the depuy synthes design instructions and roles.The surgeon approved with his signature on the approval letter the device design image.This complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions.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 - manufactured date: 18-aug-2021 a manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: product code: sd800.436.Lot number: 350p950.Manufactured date: august 18, 2021.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.The device was not received.The photo & video were received.A product development investigation was conducted by r&d team based on the available product/image/video and patient information.Design review: an investigation was conducted into the device design to determine if the design contributed or caused the issues as described in the complaint description.With the complaint one (1) intra-operative image which shows the patient situation was received.The surgeon confirmed the following design features for this psi device on 01 july 2021 temporal cut (location defined with provided image from surgeon) no predrilling holes for the full flap section the main body of both psi will be designed with a thickness of 4mm.A full flap around the psi, as per the image 1 below, with a material thickness of 1.5mm and a maximum extent of about 5mm.Offset from 1mm (standard offset is 0.2mm) were confirmed on 01 july 2021 the design review of the patient scan data received and that of the final psi device resulted that the psi device fits and match the patient situation and no mismatch could be identified.All requested features and changes were implemented in that finial design.The review of the design for the implant was created according to the relevant work instruction for psi design.The review of the case file ¿patient specific implant design review checklist¿ for this implant showed that the implant was reviewed and approved by an independent reviewer according to the relevant work instruction for psi design.Images 7 and 8 in the report show that the implanted device was not contacting the skull and had soft tissue between the implant and bone.Images 9 and 10 in the report show that the superior edge is not overlapping as was the pre-operative intent and therefore, there is a gap between the implant and bone.The device appears to have has been modified intra-operatively (image 11) and images 12 and 13 in the report show that the placement was shifted from the pre-operative plan.Therefore, we concluded there was no manufacturing or design related issues with this event.Conclusion: the complaint condition can be confirmed for the device.Per the investigation description above, the psi case files, communication, design feature request, intraoperative image and post-operative scan data were reviewed.The investigation included a review of the documentation and forms along with the surgeon complaint report.The design of the device was completed and verified as per the depuy synthes design instructions and roles.The surgeon approved with his signature on the approval letter the device design image.The device, based on the scan data/images received was not placed as intended by the user/surgeon.No definitive root cause could be confirmed, however the user deviated from the pre-operative plan, that could have led to complaint condition.This complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions.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 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.

• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12617474
• MDR Text Key: 281217726
• Report Number: 8030965-2021-08614
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: PSI SELF-DRILLING