MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71368569

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  malfunction  

Event Description

It was reported that impactor broke during the case.No delay was reported and a backup device was available.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tightening shaft fractured at the first joint.All pieces were returned.The device was manufactured in 2017 and exhibits signs of extensive wear/usage.A fracture can occur if sufficient impact forces placed upon the instrument are transferred through this constrained area.This fracture may have occurred due to a static or fatigue failure mechanism.A review of complaint history did not reveal additional complaints for the listed batch.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 OFFSET IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8307887
• MDR Text Key: 135154668
• Report Number: 1020279-2019-00398
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010600240
• UDI-Public: 03596010600240
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71368569
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1