MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 48MM; ORTHOPAEDIC BONE PIN, NON-BIOABSORBABLE

Catalog Number	71331948
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during left thr procedure, on insertion the shell was positioned and impacted with mallet onto r3 shell impactor/positioner as per standard technique.The shell impactor became loose and the tip (about 1-2mm) sheared off impactor thread and stayed wedged in the shell apex.The sheared off tip was attempted to be removed but surgeon could not twist out.Surgeon decided to remove shell as he wasn't happy leaving tip in and wasn't sure if shell was fully seated and stable.Procedure was completed with other 48mm shell.3-5 minutes delayed reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirms the stated failure.A piece of the r3 shell impactor is stuck inside the 48mm shell.The device was manufactured in 2020.A medical investigation was conducted and confirms based on the information provided, the root cause could not be definitively concluded and the patient impact beyond the negligible surgical delay could not be determined.No further medical assessment could be rendered at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible probable cause could include but not limited the user error.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 3 HOLE HA CTD ACET SHELL 48MM
• Common Device Name: ORTHOPAEDIC BONE PIN, NON-BIOABSORBABLE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10110902
• Report Number: 1020279-2020-01942
• Device Sequence Number: 16974343
• Product Code: JDH
• UDI-Device Identifier: 03596010597724
• UDI-Public: 3596010597724
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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
• Operator of Device: No Information
• Device Catalogue Number: 71331948
• Device Lot Number: 20BM10063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 02/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention