MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LINER IMPACTOR HEAD 38-42MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71363842

Device Problem Break (1069)

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

Event Date 03/25/2021

Event Type  Injury  

Event Description

It was reported that during a total hip replacement the r3 liner impactor head 38-42mm head snapped during trial.All pieces were retrieved.No harm to the patient or delay reported.The procedure was finished with the same device.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned r3 liner impactor head 38-42mm confirms pieces broke off the device.The broken pieces were not returned with the device.A medical investigation was conducted and confirms per complaint details, there was no patient harm as a result of this device related incident, and all pieces were retrieved.The procedure was completed without delay using the same device.Therefore, no further medical assessment is warranted based on the information provided.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 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 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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 LINER IMPACTOR HEAD 38-42MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11685251
• MDR Text Key: 246010302
• Report Number: 1020279-2021-03181
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010599407
• UDI-Public: 3596010599407
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71363842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention