MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RDCE FRCPS W/ SRRTD JW; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71173378

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the device was dull.A delay of 5 minutes was reported and there was no smith and nephew backup device available, they had to use the hospital sets.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.Only one device was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The cutting edges of the device were damaged with gouges in the surface, rendering the device inoperable.The device was manufactured in 2014 and exhibits signs of extensive wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: RDCE FRCPS W/ SRRTD JW
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9268909
• MDR Text Key: 164809124
• Report Number: 1020279-2019-03862
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010519542
• UDI-Public: 03596010519542
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 04/03/2020

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 Model Number: 71173378
• Device Catalogue Number: 71173378
• Device Lot Number: 13KTCD139
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1