MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.527 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number	SD800.527
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that on an unknown date, that an implant was too large and had to be modified intraoperatively.The surgeon used a drill to burr a little bit off the edge of the implant.There was a surgical delay of 5 minutes.The implant was successfully implanted into patient with no issue to outcome.The patient was reported as stable.This report involves 1 psi sd800.527 peek implant.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: h3, h6: investigation summary: the complaint device (part # sd800.527; lot # 82p5181) was not received.A product development investigation was conducted based on the available product and patient information.Design review: an investigation into the device design to determine if it may have contributed or caused the event was conducted.Patient specific implants are customized devices intended to repair defects in the cranial/craniofacial skeleton.Each psi is designed for an individual patient to conform to the specific defect, patient anatomy and surgical request.Patient ct image files are provided to depuysynthes by the requesting surgeon and imported into a segmentation system to distinguish the bony elements of the cranium from soft tissue.The result is a 3d model of the patient¿s skull showing the defect or deficiency.The 3d model is exported into cad software where, in consultation with the patient¿s surgeon, an implant is designed to match the specific geometry of the patient¿s defect or deficiency and cosmetically conform to the patient¿s anatomy.The surgeon is provided images of the patient¿s defect along with images of how the implant fits within the defect for approval.Prior to release for manufacture, the fit and symmetry of the design are checked on the cad model by the designer and an independent reviewer.The 3d cad model is then used by manufacturing to manufacture the device.Quality inspectors utilize the same cad model to optically compare the manufacture device to the cad model released by the design team.Review of the case file for this implant showed that the implant was reviewed and approved by the product designer, an independent reviewer and the requesting surgeon according to the relevant work instructions for psi design and production.Review of the device dhr also showed that the implant was inspected and passed the required checks necessary for shipment to the customer.The implant covered deficit, the shape matched the patient¿s anatomy and there was a smooth transition between the implant and the native bone.There was no evidence of the condition described in the complaint.The patients ct scan information was also reviewed as part of the investigation.The acquisition parameters met the requirements of depuy synthes¿ scanning protocol ((b)(4)) at the time of receipt.The slice thickness was 0.5mm, there was no gantry tilt present, all images shared the same image center and the defect area was free of steps.The ct scan supplied by the account was received by depuy synthes on (b)(6) 2020, which is approximately 6 weeks after the scan images were collected, (b)(6) 2020.The scan fell within the 4-month window and was accepted.It should also be noted that the ct images contained a metallic mesh from a previous surgery.This mesh was segmented from the bone in order to generate a cad model which was used as the basis of the design.This mesh would be dissected by the surgeon prior to implanting the psi device.The approval report which was provided to the surgeon for review showed the preoperative condition with the metallic mesh in place along with an image of the cranial defect with the mesh virtually removed.The report also shows images of the proposed implant design to cover the virtually dissected defect.The surgeon gave approval to proceed on (b)(6) 2020.Further review of the case file showed that this implant was shipped from depuy synthes to the account on 12/11/2020.Material of construction and packaging were reviewed and there was no evidence that the material of construction and packaging could have caused or contributed to the complaint condition and were not considered further during the investigation.Tolerance stack-up/mating parts/compatibility was reviewed as part of the design review above.Sterilization and product labeling processes were reviewed and there was no evidence that the sterilization and labeling processes or parameters could have caused or contributed to the complaint condition and were not considered further during the investigation.User technique and manufacturing specifications were reviewed and there was no evidence that the user technique and manufacturing specifications could have caused or contributed the complaint condition and were not considered further during the investigation.Conclusion: the psi investigated as part of this complaint passed all design and manufacturing quality checks as prescribed by the relevant work instructions for psi design.The investigation showed that the psi implant fit the patient¿s bony defect, did not interfere with the bone, met the thickness criteria, and was approved by the operating surgeon prior to implantation.There is no evidence that the design contributed to the complaint; thus this complaint is unconfirmed.No definitive root cause could be attributed to this complaint condition, but the investigation found that the reported event most likely occurred due to differences in the virtual removal of the metallic mesh as compared to how the surgeon dissected the mesh in-situ.Metallic objects can obscure underlying bony details due to image scatter.Small discrepancies in these regions would not be unexpected.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.Product code: sd 800.527.Lot number: 82p5181.Device history batch: part/lot combination not found.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 SD800.527 PEEK IMPLANT
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11193550
• Report Number: 2939274-2021-00348
• Device Sequence Number: 16326048
• Product Code: GXN
• UDI-Device Identifier: 10887587065861
• UDI-Public: (01)10887587065861
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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
• Operator of Device: Health Professional
• Device Model Number: SD800.527
• Device Catalogue Number: SD800.527
• Device Lot Number: 82P5181
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/22/2021
• Patient Sequence Number: 1