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

Catalog Number	71442109
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation please review attached for investigation results.
Additional 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
• Common Device Name: PRSTHSIS KNEE PATELLOFEMOROTIBIAL SMICNSTRAINED CMNTD POLYMERMETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7088664
• Report Number: 1020279-2017-01189
• Device Sequence Number: 13742996
• Product Code: JWH
• UDI-Device Identifier: 00885556494356
• UDI-Public: 00885556494356
• Combination Product (Y/N): N
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Catalogue Number: 71442109
• Device Lot Number: 16BAB0006
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 11/20/2017; 11/20/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/09/2018; 01/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization