MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 6; PROSTHESIS, KNEE, FMOROTIBIAL, SMI-CONSTRAIND, CEMENTED, METAL/POLYMR

Catalog Number 71441154

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Event Description

It was reported that there is a broken legion cutting block.It broke inside of the bone of a patient.No injuries or delays reported.S+n backup device was available.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The visual assessment confirmed one of the pegs is broken off the gii mis dcf ap ct blk 6 and has not been returned.The device shows significant signs of wear/usage.The device was manufactured in 2005.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: GII MIS DCF AP CT BLK 6
• Type of Device: PROSTHESIS, KNEE, FMOROTIBIAL, SMI-CONSTRAIND, CEMENTED, METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9370105
• MDR Text Key: 168675029
• Report Number: 1020279-2019-04149
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010497222
• UDI-Public: 03596010497222
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71441154
• Device Lot Number: 05CM15199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2019
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1