MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.440 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number SD800.440

Device Problem Defective Device (2588)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

It was reported that on (b)(6) 2021, there were issues with the fit of the psi implant.The implant had to be modified intraoperatively.Surgery was completed successfully with an unknown delay.Patient outcome is unknown.This report is for a psi sd800.440 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.Device history lot - a review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the patient specific implant (psi) was processed through the normal machining, laser etch, finishing, inspection, and packaging operations.The product lot met all specification criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.Device history review - the product lot met all specification criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.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 product was not returned to depuy synthes for evaluation.The r&d team conducted an investigation based off the case records and complaint documentation.Device design: an investigation was conducted into the device design to determine if the design contributed or caused the issues as described in the complaint description.It is noted in the design inputs document that the ct scan had a slice thickness of 3.0mm, above the required maximum slice thickness of 1.25mm.The note goes on to say that the surgeon approved this deviation in the approval letter.Ct scan slice thicknesses above specification could lead to issues with the fit of an implant but the surgeon explicitly accepted this possibility with the approval letter.Electronic device design review: the design review of the patient scan data received and that of the final psi device concluded that the psi device fit and matched the patient situation with no mismatch identified.All requested features and changes were implemented in that final design.Design process review: 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 complaint was reviewed and approved by an independent reviewer according to the relevant work instruction for psi design.Per the investigation description above, the psi case files, communication and design feature requests 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 their signature on the approval letter that the device was designed appropriately for this case in spite of the resolution of the submitted ct scan being less than the standard requirement.Furthermore, per device labeling (package insert), intra-operative modification of the implant is allowed to modify the fit of the implant.This complaint investigation identified that the surgeon explicitly approved the design of the device as created in spite of the risk of fit issues as a result of the inadequate ct scan resolution.Therefore, this non-manufacturing investigation is closed by product development 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 sd800.440 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: device history record (dhr) review conducted: part number: sd800.444; lot number: 520p883; part manufacture date: 11-19-2021; manufacturing location: brandywine; part expiration date: n/a; nonconformance noted: n/a.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the patient specific implant (psi) was processed through the normal machining, laser etch, finishing, inspection, and packaging operations.The product lot met all specification criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.The product lot met all specification criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.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 SD800.440 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13062831
• MDR Text Key: 289904296
• Report Number: 2939274-2021-07208
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587065113
• UDI-Public: (01)10887587065113
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD800.440
• Device Catalogue Number: SD800.440
• Device Lot Number: 520P883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1