MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.433 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number SD800.433

Device Problem Defective Device (2588)

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

Event Date 02/07/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2023, that the produced psi implant did not fit the patient's bone defect.Surgery was delayed for 10 minutes due to the reported event.The procedure was successfully completed.No fragments were generated.There was no patient outcome/consequences.This report is for one (1) psi sd800.433 peek implant.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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j sales representative.Device evaluated by mfr: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5 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 patient is scheduled to undergo revision surgery.This complaint, (b)(4), is related to (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: a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.Product code:sd800.433.Lot number:4147p80.Manufacturing site: mezzovico.Release to warehouse date: 19 jan 2023.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this 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.If information is obtained that was not available for this 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.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.H10 additional narrative: the product was not returned to depuy synthes for evaluation.The r&d team conducted an investigation based off the case records and complaint documentation.Scan slice thickness too large we have reviewed the dicom images and noticed that the slice thickness of the head images is 3mm.This is more than our standard acceptance criterion of 1.25mm and can therefore influence the accuracy of the planning and implant design.Please note that we wouldn¿t recommend to use images with a slice thickness bigger than 2.5mm for guide/implant design.Scan area too small we have also noticed that the provided dicom data doesn¿t entirely cover the region of interest for the services requested (refer to the picture in the report).We need at least 2cm of bone area around the defect completely scanned to proceed.Scan data has expired (date - 2022-08-01) due to safety issues the scan must be less than 4 months old at time of design and surgery should not be performed later than 6 months from the scan date, as changes in the anatomy of the patient can influence the accuracy of the planning and implant design.Per the complaint description above, the psi case files, and communication were reviewed.The investigation included an end-to-end process review of the documentation and forms along with the surgeon complaint report and the received details on the case.No images were received with the complaint.The not complying scan dataset provided (as listed under 3.4) specific for this case.Have been identified before the design work commenced and clearly communicated to the requesting surgeon with the associated risks.The requesting surgeon provided his approval to work with the not complying scan data in his email reply on 2023-01-13.The implant design was completed and verified as per the design instructions and roles.After the surgeon reviewed the design and approved it (with his signature), the device was produced and inspected according to process and released upon acceptable quality inspection.It is indeterminate if the following points had an influence on the intra-operative situation or not: ¿ the requested 0.4mm offset between the patient bone and implant device.(standard value is 0.2mm) ¿ the slice thickness of the skull images with 3mm.(requirement is 1.25mm) ¿ the provided dicom data doesn¿t entirely cover the region of interest.(requirement 2cm around the area of interest) ¿ the scan was more than 4 months old at the time of device design.(requirement is less than 4 months old) based on the information and documents available, this design investigation is closed as not valid regarding a design related root cause.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the psi sd800.433 peek implant.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H6 product code:sd800.433 lot number:4147p80 manufacturing site: mezzovico release to warehouse date: 19 jan 2023 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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: PSI SD800.433 PEEK IMPLANT
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16466202
• MDR Text Key: 310499959
• Report Number: 8030965-2023-02538
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065069
• UDI-Public: (01)10887587065069
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD800.433
• Device Catalogue Number: SD800.433
• Device Lot Number: 4147P80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1