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

Model Number V0200109

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 01/31/2020

Event Type  Injury  

Event Description

It was reported that during a bilateral visionare case performed on (b)(6) 2020 the right-sided visionaire block appears to be 3 to 5 degrees added in compared to the traditional sizing guide which was set to 0 and 3 degrees.When drilling these holes again through the sizing guide there was a completely different set of holes mm apart which was a clear indication the visionaire drill holes for the 4:1 block rotation were incorrect.Surgeon completed the left side first successfully using the blocks and did not encounter this problem and he used verasense which indicated a well-balanced knee further indicating that the rotation on the l side was correct.

Manufacturer Narrative

It was reported that during a case the right-sided visionaries block appears to be 3 to 5 degrees added in compared to the traditional sizing guide which was set to 0 and 3 degrees.Surgeon completed the left side successfully using the blocks.The affected visionaries adaptive guide, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation including an engineering review by our visionaries team noted that after evaluation, it was found that the case was within the visionaries standards.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Ifu review yields that there exists instruction to revert to standard instrumentation if the user observes unsatisfactory performance of device.Risk assessment review noted the failure has been managed by dfmea.No medical records were provided.Without supporting medical documentation, a thorough medical assessment cannot be performed.Some potential cause of the reported event could include but is not limited to the surgical technique used.

• Brand Name: NS VIS ADPT GUIDE LGNP KIT
• Type of Device: PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9677003
• MDR Text Key: 177986408
• Report Number: 1020279-2020-00491
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

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: 04/01/2020
• Device Model Number: V0200109
• Device Catalogue Number: V0200109
• Device Lot Number: 00165078V1
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention