MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH UNIVERSAL CUT BLOCK; PRSTHSIS KNEE PATELLOFEMOROTIBIAL SMICNSTRAINED CMNTD POLYMERMETAL

Catalog Number 71442109

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  malfunction  

Event Description

It was reported that even though the orthomatch universal primary cutting block was attached firmly the alignment was incorrect resulting in a valgus determination on the femoral cuts and poor inclination on the tibial cuts.

Manufacturer Narrative

The associated complaint device was not returned for evaluation please review attached for investigation results.

Manufacturer Narrative

The universal cut block was returned and evaluated.A visual inspection found that the device had sharp burs around both sides of the cutting guide.Some abrasions were also noticed throughout the device.Additionally, a dimensional inspection was attempted; however the damage and deformation at several features of the device would not allow for accurate measurement.Finally, clinical investigation concluded the following: without sufficient clinically relevant supporting documentation, a thorough medical assessment and/or causal relationship cannot be provided.The patient impact beyond possible instability from the reported poorly maintained flexion/extension gap and the 45 minute surgical extension cannot be concluded.No further medical assessment is warranted at this time.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.

• Brand Name: ORTHOMATCH UNIVERSAL CUT BLOCK
• Type of Device: PRSTHSIS KNEE PATELLOFEMOROTIBIAL SMICNSTRAINED CMNTD POLYMERMETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7088664
• MDR Text Key: 94143220
• Report Number: 1020279-2017-01189
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556494356
• UDI-Public: 00885556494356
• Combination Product (y/n): N
• PMA/PMN Number: K142807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2019

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
• Device Operator: Physician
• Device Catalogue Number: 71442109
• Device Lot Number: 16BAB0006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 11/20/2017; 11/20/2017
• Supplement Dates FDA Received: 03/09/2018; 01/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization