MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LNR MPACTOR HD II 28MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71366428
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the r3 lnr mpactor hd ii 28mm broke during a thr procedure upon impaction.There was no delay.Procedure concluded with a s&n back up device.No other complications reported at this time.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports that the liner impactor broke during impaction.Per complaint details, the procedure was completed without patient injury or delay, using a backup device.A photo of the broken piece confirms it was removed from the patient.Therefore, since no patient harm is alleged, no further clinical assessment is warranted.A visual inspection confirmed base is broken off the r3 offset impactor.The device shows significant signs of wear/usage.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.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.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.

• Brand Name: R3 LNR MPACTOR HD II 28MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11205276
• Report Number: 1020279-2021-00515
• Device Sequence Number: 11783590
• Product Code: JDG
• UDI-Device Identifier: 03596010656056
• UDI-Public: 03596010656056
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71366428
• Device Catalogue Number: 71366428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention