MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD420.427 TITANIUM IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NON ALTERABLE

Model Number	SD420.427
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record.Device history lot product code: sd420.427.Lot: 27p9142.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 batch null, device history review a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Investigation summary complaint summary it was reported on december 16, 2019, an unknown patient-specific implant that was manufactured by depuy synthes and the manufacturing would not completed two specifications.A certain part number for the plate to be manufactured and into the provision and a different part number was manufactured to it.It is unknown if there were a procedure and patient involvement.This complaint involves one (1) device.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 requested that 14mm x 14mm ti matrix neuro box plates be used to secure the implant in place.These plates have a hole spacing of 10mm.Review of the digital models revealed that the holes provided in the implant were spaced at 14mm, not 10mm for the plate requested.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 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.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.
Event or Problem Description
It was reported that on an unknown date, the patient specific implant had incorrect space plating holes for the requested plates.The sales consultant indicated that they intend to use a different style plate to fit the current hole system without obstructing original surgery date and time.There was no patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: PSI SD420.427 TITANIUM 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: 9936413
• Report Number: 2939274-2020-01758
• Device Sequence Number: 752485
• Product Code: GXN
• UDI-Device Identifier: 10887587069746
• UDI-Public: (01)10887587069746
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: K033868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD420.427
• Device Catalogue Number: SD420.427
• Device Lot Number: 27P9142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1