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

Model Number 71364450

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the threads on the r3 straight shell impactor are damaged and cannot thread anything onto it.No case involved; therefore, no patient involvement.

Manufacturer Narrative

It was reported that threads are damaged and cannot thread anything onto it.No case involved; therefore, no patient involvement.The affected complaint device, intended for use in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.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.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.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: 11230530
• MDR Text Key: 228700456
• Report Number: 1020279-2021-00597
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• 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
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1