MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number 71363077

Device Problem Break (1069)

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

Event Date 06/07/2021

Event Type  Injury  

Event Description

It was reported that during a total hip arthroplasty on june 7th, when surgeon was impacting an r3 shell size 50, the r3 offset impactor tip broke on the last impaction.The black plastic pieces were retrieved and no pieces were noticed when surgeon x-rayed the hip.The procedure was finished using a smith and nephew back up device without delays.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was broken into multiple pieces, rendering the device inoperative.The device shows signs of extensive use.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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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.

• Brand Name: R3 OFFSET IMPACTOR TIP
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12053652
• MDR Text Key: 257895346
• Report Number: 1020279-2021-05388
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010599391
• UDI-Public: 03596010599391
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71363077
• Device Catalogue Number: 71363077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention