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

Model Number V0200109

Device Problems Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a tka, using an unkn visionaire cut guide instr for legion primary cr tka surgery caused notching during the anterior resection due to engineer¿s alignment.The procedure was completed, after a non-significant delay, with a change in surgical technique.No other complications reported.Patient is healthy and recovering normally from surgery.

Event Description

It was reported that, during a visionaire-assisted tka with legion primary cr, the surgeon caused notching during the anterior resection due to engineer¿s alignment to design the block.There was no noticeable poor alignment prior to making resections.The procedure was completed, after a non-significant delay, with a change in surgical technique.No other complications reported.Patient is healthy and recovering normally from surgery.

Manufacturer Narrative

B5: describe event or problem, d1: brand name, d2a: common device name, d2b: procode, d4: catalog#, lot#, expiration date, unique identifier (udi)# , h4: device manufacture date, g5: pma/510(k)#: section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the documentation provided, no clinical factors have been identified which would have contributed to the reported event.The assessed patient impact includes the anterior notching, the reported slight (0-30 minute) surgical delay, and the anticipated post-operative rehabilitative phase.Although controversial, anterior notching has been associated with a possible increased risk for periprosthetic fractures and early revision; however, this cannot be concluded.Per correspondence, the patient is healthy and recovering normally.Further patient impact cannot be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.As visionaire devices are custom made devices, a review of the complaint history for this part is not applicable.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting guide does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.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.A review made by the quality engineering team revealed that after a thorough review of the device standards, the engineering team could not determine a root cause for this complaint.All parts of the designed device were within the visionaire standards.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used, user/procedural variance or segmentation error.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.H6: health effect - clinical code and medical device problem code.

• Brand Name: NS VIS ADPT GUIDE LGNP KIT
• Type of Device: 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: 15535509
• MDR Text Key: 301084234
• Report Number: 1020279-2022-04285
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: V0200109
• Device Catalogue Number: V0200109
• Device Lot Number: 00237681V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention