MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI PATIENT SPECIFIC PLATE MANDIBLE/ W/O ANGLE/2.0MM THK; BONE PLATE

Model Number SD480.112

Device Problem Defective Device (2588)

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

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on an unknown date during an unknown procedure that neither of the left or right of the patient-specific mandible plate fit the bone deficit.The procedure was completed successfully however the implants were not implanted.The patient outcome was unknown.This complaint involves two (2) devices.This report is for (1) ti patient specific plate mandible/ w/o angle/2.0mm thk.This report is 2 of 2 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.H10 additional narrative: h3, h6: part number: sd480.112-us lot number: 82p3848 part manufacture date: december 9, 2020 manufacturing location: elmira part expiration date: n/a nonconformance noted: n/a dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti patient specific plate mandible/ w/o angle/2.0mm thk product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The complaint device (part # sd480.112; lot # 82p3848) 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.Pspm plates (patient specific plate for mandible) are customized devices intended to repair/reconstruct mandible defects.Each pspm is custom contoured for an individual patient.The plate is designed and manufactured using proprietary software to produce a mandible plate which conforms the specific defect/reconstruction, patient anatomy and surgical request.Patient ct image files are provided to depuysynthes¿ planning partner by the requesting surgeon and imported into a segmentation system to distinguish the bony elements of the mandible from soft tissue.The planning partner, in consultation with the patient¿s surgeon, simulates resection and or reconstruction of the patient¿s mandible using the planning partner proprietary software.The planning session also plans the occlusion of the patient¿s teeth.This occlusion is maintained during the surgery by an intraoral split.The splint and associated guides are designed and manufactured by the planning partner as the legal manufacturer.The output of the surgical planning session is a digital file (.Stl) of the planned reconstruction suitable for import into the pspm design software (synopsis).Once the pspm plate is designed and manufacturability verified; the surgeon is provided a combined case report for approval.The report contains the reconstruction planned by the planning partner's team along with images of the plate(s) showing how the implant(s) fit the planned reconstruction.Prior to release for manufacture, the pspm design is reviewed for compliance to defined design and fit specifications along with confirmation of surgeon approval.Review of the case file for this case showed that the implants were reviewed and approved by the product designer, an independent reviewer and the requesting surgeon according to the relevant work instructions for pspm design and production.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 pspm implant investigated as part of this complaint passed all design and manufacturing quality checks as prescribed by the relevant work instructions for pspm design.The investigation revealed that the pspm was contoured according to the resection boundaries specified by the requestors and the plate matched the contour of the 3d model planned reconstruction; thus this complaint is unconfirmed.No definitive root cause could be attributed to this complaint condition.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 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: TI PATIENT SPECIFIC PLATE MANDIBLE/ W/O ANGLE/2.0MM THK
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11147008
• MDR Text Key: 226026541
• Report Number: 2939274-2021-00145
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587005348
• UDI-Public: (01)10887587005348
• Combination Product (y/n): N
• PMA/PMN Number: K122647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD480.112
• Device Catalogue Number: SD480.112
• Device Lot Number: 82P3848
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention