MAUDE Adverse Event Report: SYNTHES GMBH PSI SD800.434 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.434

Device Problem Defective Device (2588)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in china as follows: it was reported that on (b)(6) 2023, while preparing the customized peek implant for cranial repair surgery, it was found that the size and shape of the product did not match with the customized ct data.The surgeon stopped the surgery immediately.The patient is in stable condition.This report involves one psi sd800.434 peek 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: initial reporter facility name: children's hospital affiliated to chongqing medical university.H3, h6: 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.H6: the complaint device was evaluated and investigated by r&d.The product was not returned to depuy synthes.The r&d team conducted an investigation of the device from the complaint documentation and case records.The returned photos were not separately investigated as their condition was adequately addressed through the r&d report.The scan contained within (b)(4) confirm the patient¿s name within the scan header fields and the name logged in windchill.The segmented data shows the 3d reconstruction of the skull with a large defect on the patient¿s left side.Ct scan header fields were reviewed.The scan was shown to meet the scan protocol for acceptable values and header values these were identical to the noted values on the scan intake form.The data up-load and device generation by psia under case number tcmf-2198230 is correct.Review of images received from customer: the cycled image clearly shows the contour of the case (b)(4).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 including the provided images of the wrong device.The implant design was completed and verified as per the depuy synthes 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.Despite the device not being returned for evaluation, it is determined based on the documents, process steps and files reviewed, that the designer pulled the case files from the psia repository of case id: (b)(4) and incorrectly saved the files under the case number (b)(4) and name.This was not identified during the remaining process steps, surgeon and independent reviews.The manual file transfer between the two systems: psia and windchill, led to a human error via the downloading of the incorrect design files and with that the wrong device shipment.Note: the review of the case files of (b)(4) concluded that there are no incorrect files pulled from psia to windchill and therefore no actions are required for this case.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the psi 120*100*40 peek.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part number: sd800.434 lot number: 6405p86 manufacturing site: mezzovico release to warehouse date: 31 may 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.

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.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 SD800.434 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 CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17388882
• MDR Text Key: 319759610
• Report Number: 8030965-2023-09253
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341340
• UDI-Public: (01)07611819341340
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD800.434
• Device Lot Number: 6405P86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1