MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 7 RT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71433357
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the piece broke off near gap in the middle.No broken piece was left in the patient or fell in the patient.No harm to the patient was recorded.A backup device was available and no delay was reported.
Additional Manufacturer Narrative
The associated genesis ii spc ream through trial was returned and evaluated.Visual examination showed a fracture and deformation of the fixation rails in the ream through slot of the femoral trial.The broken piece is returned with the complaint.The fracture and deformation is likely due to the load applied to the trial during the impaction of the trial onto the femur.If the loads applied exceed the strength of the material, a fracture may occur.The device was manufactured in 2009 and it shows significant signs of wear/usage.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation including a review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.

• Brand Name: GII SPC REAMTHRU CR TR SZ 7 RT
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8325138
• Report Number: 1020279-2019-00504
• Device Sequence Number: 206793
• Product Code: MBH
• UDI-Device Identifier: 00885556031582
• UDI-Public: 00885556031582
• 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): 03/03/2019

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: Health Professional
• Device Catalogue Number: 71433357
• Device Lot Number: 10FM07987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1