MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE LGNP FEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	V0100107
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka surgery using visionaire femoral cutting block, more bone was resected from the femoral posterior medial condyle than planned.The planned cut was 9.5mm, but the measured resection with a caliper was 12.5mm.The procedure was resumed after a significant delay, with a change in surgical technique.No further information is available.
Additional Manufacturer Narrative
H10: internal complaint reference:(b)(4).
Additional Manufacturer Narrative
H6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, there is a definitive clinical root cause.There were no clinical factors found which would have contributed to the event.The instruction for use does note to use standard smith and nephew instrumentation to complete the surgery if the patient-matched cutting block does not perform as intended.According to the report, the procedure was resumed after a significant delay, with a change in surgical technique.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that, it was determined that the anterior femur was under segmented by the segmenter and alignment engineer, causing the block to fit in an incorrect position.The engineers are to be made aware of mistakes made in the segmentation.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.Visionaire devices are patient-matched instruments, therefore, no additional review was performed for the batch number.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to inspection drawing, part number, size, implant type, hand, recut type and sawblade thickness shall be verified.Also, part configuration shall be compared to print.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be under segmentation of the anterior femur.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: VIS ADPT GUIDE LGNP FEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19029206
• Report Number: 1020279-2024-00662
• Device Sequence Number: 6992079
• Product Code: JWH
• UDI-Device Identifier: 00885556656372
• UDI-Public: 00885556656372
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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 Expiration Date: 07/01/2024
• Device Catalogue Number: V0100107
• Device Lot Number: 00272882V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male