MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 5; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71441153
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the metal piece between chamfer cut guides broke off.A backup device was available and no delay was reported.
Additional Manufacturer Narrative
The associated genesis ii minimally invasive ap cutting block was not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Thus, review of the manufacturing records and complaint history were conducted.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Without the return of the actual product involved, our investigation of this report is inconclusive.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there is not confirmation that the device broke inside or over the patient´s incision, neither any fragment of the device fell inside the patient, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GII MIS DCF AP CT BLK 5
• 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: 8324772
• Report Number: 1020279-2019-00503
• Device Sequence Number: 13882434
• Product Code: MBH
• UDI-Device Identifier: 03596010497215
• UDI-Public: 03596010497215
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2019

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: 71441153
• Device Lot Number: 14KM21087
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 06/05/2019; 01/21/2019
• Initial Report FDA Received Date: 02/10/2019
• Supplement Report FDA Received Date: 06/08/2019; 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1