MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 STRAIGHT SHELL IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71364450

Device Problems Flaked (1246); Mechanical Problem (1384); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the spring in the middle of the r3 straight shell impactor is no longer effective and is cross threaded at the connection with the impactor tip.Fault in devices was noticed during set up or inspection.A s+n backup device was available to complete the procedure.No surgical delay or harm to any patient occurred was reported.

Manufacturer Narrative

H6: the associated device, intended for used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threaded end of the device is fractured, rendering the device inoperable.The device was manufactured in 2019 and shows signs of extensive use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 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 STRAIGHT SHELL IMPACTOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10913369
• MDR Text Key: 218639468
• Report Number: 1020279-2020-06850
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010607034
• UDI-Public: 03596010607034
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/12/2021

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: 71364450
• Device Catalogue Number: 71364450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/12/2021
• Patient Sequence Number: 1