MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN AP FEM CUTTING BLK SZ 4; PRSTHSS,KNEE,PTLL/FMRTBL,SMI-CNSTRIND,UNCMTD,PRS,

Catalog Number	71434409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the block broke apart while the surgeon was cutting through it.Procedure was completed with a smith & nephew device size 5.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured in half, rendering it inoperable.Both pieces were returned.The area near the fractures showed signs of possible gouging from the saw blade.The cause for the cutting block fracture was likely due to the cutting blade gouging the cutting block in the area where the anterior and posterior portions of the block are connected in combination with the small cross-sectional area of that region.This could raise the stresses in that region and reduce the load necessary to cause fracture of the cutting block.The device was manufactured in 2006 and shows signs of extensive use.The medical investigation concluded that this complaint from the united states reports that a cutting block broke apart during use.Further, it was reported that the procedure was completed using the next size up smith & nephew cutting block.Also, it was stated that there was no delay in the procedure and no patient harm.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.

• Brand Name: LGN AP FEM CUTTING BLK SZ 4
• Common Device Name: PRSTHSS,KNEE,PTLL/FMRTBL,SMI-CNSTRIND,UNCMTD,PRS,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10089818
• Report Number: 1020279-2020-01863
• Device Sequence Number: 16739061
• Product Code: MBH
• UDI-Device Identifier: 03596010549174
• UDI-Public: 3596010549174
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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
• Operator of Device: No Information
• Device Catalogue Number: 71434409
• Device Lot Number: 16CM16424
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention