MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN VISIONAIRE CUT GUIDE INSTR; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number UNKN01400400

Device Problem Nonstandard Device (1420)

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

Event Date 03/01/2021

Event Type  Injury  

Event Description

It was reported that when positioning the visionaire femoral cutting block, the surgeon expressed concern that the block appeared to be taking off more bone distally than was stated in plan.Post distal femoral cut, the surgeon measured the resected bone with the calipers and noted that both (medially and laterally) the resected bone was approximately 2mm more than was stated in the plan (plan stated 9.5 medial resection and 7.5 lateral resection, the resected bone measured 11/12mm medially and 9/10mm laterally).Next, when the 4 in 1 block was positioned he noted that a large amount of bone was being resected posteriorly (more than plan stated) and moved the 4 in 1 block down to prevent removing too much bone posteriorly.Surgeon noted that although he adjusted the block posteriorly he still required an 11mm poly to balance the knee.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, the surgeon suspected the femoral block was taking off more bone distally than planned; therefore, the surgeon ¿moved the block down to prevent removing too much bone posteriorly¿.Per the anz complaint form, the surgeon measured the resected bone (post distal femoral cut) medially and laterally to be approximately 2mm more than planned.¿plan stated 9.5 medial resection and 7.5 lateral resection, the resected bone measured 11/12mm medially and 9/10mm laterally¿.Reportedly, although the surgeon adjusted the block posteriorly, the procedure ¿still required an 11mm poly¿ (planned) to balance the knee.¿no root cause could be determined for the reported discrepancy between the planned femur resection depth and the actual measured femur resection depth¿ per the engineering evaluation, as all was within the acceptance criteria.The requested clinical documentation was not provided for inclusion in the medical investigation.Based on the information provided, the clinical root cause could not be determined.Although the surgeon reportedly believed the block did not match his preferences, the engineering evaluation did not identify a block discrepancy.Reportedly, a 0-30 minute surgical delay resulted from the event with a change in surgical technique; however, no patient injury was reported.Further patient impact would not be anticipated, as the reported intra-op adjustments allowed use of the planned 11mm insert and no patient injury was reported.No further medical assessment could be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: UNKN VISIONAIRE CUT GUIDE INSTR
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11548687
• MDR Text Key: 241677600
• Report Number: 1020279-2021-02324
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K170282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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: 07/24/2021
• Device Catalogue Number: UNKN01400400
• Device Lot Number: 00189957V1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention