MAUDE Adverse Event Report: SYNTHES GMBH PSI 140*120*40 PEEK; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number SD800.440

Device Problem Defective Device (2588)

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

Event Date 12/01/2022

Event Type  malfunction  

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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Initial reporter name and address: (b)(6).Mfr postal code-2544.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, a follow-up will be filed as appropriate.

Event Description

Device report from synthes reports an event in korea, south as follows: the manufactured psi did not fit the patient's bone at all.(totally different) surgery was delayed for 30 minutes.They finished the operation with a medpore.The procedure successfully was completed.Fragments were not generated.There was no patient outcome and consequences.This report is for one (1) psi 140*120*40 peek.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: a1: patient id reported as (b)(6).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.Note: the complaint device was evaluated and investigated by depuy synthes r&d.The photo was returned to depuy synthes and sent to depuy synthes r&d for evaluation.The depuy synthes r&d team conducted a visual inspection of the returned device.Visual analysis of the photo was performed on psi 140*120*40 peek.Per the complaint condition, the psi case files and communication were reviewed.The investigation included a review of the documentation and forms along with the surgeon complaint report provided intra operative images, and the implant design.The design was completed and verified as per the depuy synthes design instructions and roles.The surgeon reviewed the design and approved (with his signature) the approval letter of the specific device based on the data provided to the trumatch trauma/cmf team.The design was created per the request and reviewed by the surgeon.The design approval was given on oct.19, 2022.The design review of the uploaded scan and the psi device show that the psi device fits and matches the defect.Although there appears to be several potential factors which may have contributed to the complaint description, communication and intent of the soft tissue during the surgery, this complaint investigation did not identify a design defect or deficiency which potentially contributed to the reported complaint conditions.Therefore, this non-manufacturing investigation is closed by product development as indeterminate regarding a design related root cause.Surgical technique assessment: in review of the images, there is presence of soft tissue lateral to the implant.This volume of soft tissue must be moved/relocated in order provide ample space for the peek psi implant to fit the boney margin.It is unknown to depuy synthes (trumatch trauma/cmf team) what the surgical plan was for the soft tissue, the type of tissue (i.E.Muscle, fat, facia, dermis, etc.), as well as the positioning of the tissue.Therefore, it is indeterminate as to the extent of the surgical technique¿s impact on the fit of the implant to the native bone.The dimensional inspection was not performed since the device was not returned.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 140*120*40 peek.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.Drawing/specifications reviewed? yes, reviewed.Device history product code: sd800.440.Lot number: 2733p58.Manufacturing site: mezzovico.Release to warehouse date: 25 oct 2022.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.

• 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: 16042333
• MDR Text Key: 308196869
• Report Number: 8030965-2022-11466
• Device Sequence Number: 1
• Product Code: GXN
• 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

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
• Device Catalogue Number: SD800.440
• Device Lot Number: 2733P58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 01/25/2023; 02/07/2023
• Supplement Dates FDA Received: 01/30/2023; 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1