MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD420.526 TITANIUM IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number SD420.526

Device Problem Defective Device (2588)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is j&j employee.(b)(4).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 on (b)(6) 2019, a patient-specific implant (psi) manufactured by depuy synthes was not manufactured to the specifications for a psi case.Through emails the design was confirmed to have holes drilled into the titanium implant to fit a ti matrixneuro box plate (04.503.073) but it was manufactured with drill holes spaced for ti matrixneuro box plate (04.503.065).Luckily surgeon was able to find 4 x 04.503.065 from the other trays and the surgeon and patient were happy but this could have gone very wrong.It is unknown if there were a procedure and patient involvement.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.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: 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.H11: corrected data: g4: awareness date reported on follow up 2 report as december 26, 2019 but should have been february 26, 2020.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.Lot number updated.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: h3, h4, h6: product code: sd420.526 lot: 29p5916 device released to warehouse: december 05, 2020 review of the device history record showed that the device in question passed all required inspections for thread profile and plate retention.There were no manufacturing or inspection items which could have contributed to this event.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The device was not returned to customer quality.Investigation of design documents was performed by synthes product development.A review of the patient specific case file showed that on (b)(6) 2019, the surgeon specified that 10mm x 16mm ti matrix neuro plates (04.503.073) would be used to secure the patient specific implant (psi) in place.Further review of the digital models revealed that the holes provided in the psi were spaced for 14mm x 14mm matrix neuro plates (04.503.065) in error.Review of the drawings revealed no issue with the design drawings.Conclusion the complaint was confirmed during investigation.The manufacturing and inspection process was executed per procedure and passed all quality checks per the instructions provided by the design team.Prior to releasing to production, each psi implant design is reviewed by an independent designer (i.E.A peer designer who was not involved in generation of the design).This review is documented where an independent designer is asked if the digital model file, which is used to manufacture the part, contains the proper geometry at the proper spacing for the requested fixation.While the geometry specified was for a valid fixation device, the spacing of the holes was not correct for the fixation model number requested by the surgeon.The form and the subsequent design package, which includes the digital model file used for manufacturing, was approved by the independent designer and the part was manufactured as normal.Relevant actions have been taken to address the issue.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 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.The device was not returned to customer quality.Investigation of design documents was performed by synthes product development.A review of the patient specific case file showed that on (b)(6) 2019 the surgeon specified (sales order #: 57605769 so) that 10mm x 16mm ti matrix neuro plates (04.503.073) would be used to secure the patient specific implant (psi) in place.Further review of the digital models (psi implant model wc#: 500371282) revealed that the holes provided in the psi were spaced for 14mm x 14mm matrix neuro plates (04.503.065) in error.Review of the following drawings revealed no issue with the design.Conclusion: the complaint was confirmed during investigation.The manufacturing and inspection process was executed per procedure and passed all quality checks per the instructions provided by the design team.Prior to releasing to production each psi implant design is reviewed by an independent designer (i.E.A peer designer who was not involved in generation of the design).This review is documented on form f-s581 where an independent designer is asked if the digital model file, which is used to manufacture the part, contains the proper geometry at the proper spacing for the requested fixation.While the geometry specified was for a valid fixation device, the spacing of the holes was not correct for the fixation model number requested by the surgeon.The f-s581 and the subsequent design package, which includes the digital model file used for manufacturing, was approved by the independent designer and the part was manufactured as normal.Capa has been created to address this issue.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: sd420.526.Lot: 29p5916.Review of the device history record showed that the device in question passed all required inspections for thread profile and plate retention.There were no manufacturing or inspection items which could have contributed to this event.Device history review.A manufacturing record evaluation was performed for the finished device 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 SD420.526 TITANIUM IMPLANT
• Type of Device: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9582021
• MDR Text Key: 176968878
• Report Number: 2939274-2020-00145
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 10887587068527
• UDI-Public: (01)10887587068527
• Combination Product (y/n): N
• PMA/PMN Number: K033868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD420.526
• Device Catalogue Number: SD420.526
• Device Lot Number: 29P5916
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention