MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN AP FEM CUTTING BLK SZ 4; PSTHSS, KNEE, PTLL/FMRTBL, SM-CNSTRND, UNCMNTD, PRS, CATD, PLMR/MTL/PLMR

Catalog Number	71434409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while evising a zimmer uni knee to a s&n legion revision knee, cutting block sheared in half while trying to make champher cuts.Doctor had to "free hand" cut the femur.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual examination of the returned block indicated that the two small junctions between the two larger sections of the cutting block were fractured.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.A review of complaint history did not reveal additional complaints for the listed batch.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN AP FEM CUTTING BLK SZ 4
• Common Device Name: PSTHSS, KNEE, PTLL/FMRTBL, SM-CNSTRND, UNCMNTD, PRS, CATD, PLMR/MTL/PLMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7688847
• Report Number: 1020279-2018-01276
• Device Sequence Number: 1018401
• Product Code: MBH
• UDI-Device Identifier: 03596010549174
• UDI-Public: 03596010549174
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71434409
• Device Lot Number: 06CM16813
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/15/2018
• Supplement Report FDA Received Date: 07/31/2018
• Patient Sequence Number: 1