MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAPTURED FLEXIBLE SCREWDRIVER; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71362291

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the instrument cannot be reprocessed cleanly.Despite manual cleaning, black-brown, dried particles fall out intraoperatively.No injuries or delays were reported no batch number displayed.

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 the debris found within the device was never in contact with the patient's body, so no pieces fell or were retrieved accordingly, 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: CAPTURED FLEXIBLE SCREWDRIVER
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8236998
• MDR Text Key: 132778991
• Report Number: 1020279-2019-00111
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010463531
• UDI-Public: 03596010463531
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71362291
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1