MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDUCTION FORCEPS {} 205MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71170044

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, the tip of forcep was found bent out of alignment when the tray was opened.There was a delay of less than 5 min.A competitor's device was called into the room and tried.No patient injury.

Manufacturer Narrative

The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: REDUCTION FORCEPS {} 205MM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9247973
• MDR Text Key: 164597497
• Report Number: 1020279-2019-03754
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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: 71170044
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1