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

Model Number 71364450

Device Problems Break (1069); Connection Problem (2900); Material Deformation (2976)

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

Event Date 08/05/2021

Event Type  malfunction  

Event Description

It was reported that a the threaded end of a r3 straight shell impactor is stripped and the base capture broke off and will not secure.As this was noticed in a non-surgical environment, there was not any patient involved.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection was conducted and confirms the weld on the bottom x-bar clamp fractured.This device exhibit signs of significant wear/ usage.A complaint history review found related failures; this failure mode will be monitored for future complaints 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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 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: 12343251
• MDR Text Key: 267294831
• Report Number: 1020279-2021-06481
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010607034
• UDI-Public: 03596010607034
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: 20BSA0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1