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	11/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the impactor broke during operation, inside the patient.All pieces were recovered.Surgical delay less than 30 minutes.The procedure finished with a smith and nephew backup device.Patient injuries were not reported.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection confirms the black coating on the device fractured into several pieces.All pieces were returned with the device.The product marking is fading from the device as well.The device was manufactured in 2012.The device exhibits signs of extreme wear and use.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 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.Internal complaint reference number: (b)(4).

• 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: 10912573
• Report Number: 1020279-2020-06799
• Device Sequence Number: 3317723
• Product Code: JDG
• UDI-Device Identifier: 03596010656056
• UDI-Public: 03596010656056
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 12FSY0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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